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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DRGEM - 08800011140090

400V3~ / 150kV
DRGEM Corporation
GXR-82SD
In Commercial Distribution

  • 08800011140090 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140076

400V3~ / 150kV
DRGEM Corporation
GXR-52SD
In Commercial Distribution

  • 08800011140076 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140052

220-230V~ / 125kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140052 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140038

220-230V~ / 125kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140038 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088670560

The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC70
In Commercial Distribution

  • 08806088670560 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088582412

The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM85
In Commercial Distribution

  • 08806088582412 ()


  • Mobile basic diagnostic x-ray system, digital

NA - 08806088566313

The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A
In Commercial Distribution

  • 08806088566313 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088565231

The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC85A
In Commercial Distribution

  • 08806088565231 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088520971

The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A-65
In Commercial Distribution

  • 08806088520971 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088511153

The GM60A-32S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-32S
In Commercial Distribution

  • 08806088511153 ()


  • Mobile basic diagnostic x-ray system, digital

NA - 08806088351889

The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50A
In Commercial Distribution

  • 08806088351889 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088351872

The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50
In Commercial Distribution

  • 08806088351872 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088088266

The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-40S
In Commercial Distribution

  • 08806088088266 ()


  • Mobile basic diagnostic x-ray system, digital

NA - 08806086403467

The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC80
In Commercial Distribution

  • 08806086403467 ()


  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046002548

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
Soltus 450
In Commercial Distribution

  • 08436046002548 ()
10451-03

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002531

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
Soltus 450
In Commercial Distribution

  • 08436046002531 ()
10451-02

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002517

The SEDECAL X PLUS LP PLUS Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X PLUS LP PLUS
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046002494

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
PhoeniX
In Commercial Distribution

  • 08436046002494 ()
1050

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002487

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
PhoeniX
In Commercial Distribution

  • 08436046002487 ()
1040

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002470

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
PhoeniX
In Commercial Distribution

  • 08436046002470 ()
1032

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002463

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
Soltus 500
In Commercial Distribution

  • 08436046002463 ()
10501-1

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002456

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
Soltus 500
In Commercial Distribution

  • 08436046002456 ()
10501

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002449

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
Soltus 500
In Commercial Distribution

  • 08436046002449 ()
10501-3

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002432

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
Soltus 500
In Commercial Distribution

  • 08436046002432 ()
10501-2

  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002388

The CHALLENGEX AP Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Radiographic System Challenge X
In Commercial Distribution

  • 08436046002388 ()
ChallengeX AP

  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046002364

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
PhoeniX
In Commercial Distribution

  • 08436046002364 ()
1020

  • Mobile basic diagnostic x-ray system, digital

Philips - 08436046002357

Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography
SEDECAL
MobileDiagnost wDR 2.2
In Commercial Distribution

  • 08436046002357 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002340

These Analog or Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
MULTIRAD
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046002333

These Analog or Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
MILLENNIUM
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046002319

The Proteus XR/f AT Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Proteus XR/f AT
In Commercial Distribution

  • 08436046002319 ()


  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046002302

The Proteus XR/f ET Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Proteus XR/f ET
Not in Commercial Distribution

  • 08436046002302 ()


  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046002296

The Proteus XR/f ST Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Proteus XR/f ST
Not in Commercial Distribution

  • 08436046002296 ()


  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046002234

These Analog or Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
MULTIRAD (PROTEUS XR/e)
In Commercial Distribution

  • 08436046002234 ()


  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046002173

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
MobileDiagnost wDR
Not in Commercial Distribution

  • 08436046002173 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002166

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-40HF-B-D-VIR
Not in Commercial Distribution

  • 08436046002166 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046002142

This Analog or Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
RAD SYSTEM NOVA ST
In Commercial Distribution

  • 08436046002142 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046002135

This Analog or Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
RAD SYSTEM NOVA AT
In Commercial Distribution

  • 08436046002135 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046002128

This Analog or Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
RAD SYSTEM NOVA FA
In Commercial Distribution

  • 08436046002128 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046002050

These Analog or Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
MILLENNIUM (Proteus XR/i)
In Commercial Distribution

  • 08436046002050 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046001916

This Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
MILLENNIUM PLUS AT
In Commercial Distribution

  • 08436046001916 ()


  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital

SEDECAL - 08436046001893

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
SEDECAL
SPSL8HC
In Commercial Distribution

  • 08436046001893 ()


  • Portable basic diagnostic x-ray system, digital

SEDECAL - 08436046001886

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest,abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
SEDECAL
SPSL4HC
In Commercial Distribution

  • 08436046001886 ()


  • Portable basic diagnostic x-ray system, digital

SEDECAL - 08436046001879

This is a portable digital diagnostic x-ray system Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSLW8
In Commercial Distribution

  • 08436046001879 ()


  • Portable basic diagnostic x-ray system, digital

SEDECAL - 08436046001862

This is a portable digital diagnostic x-ray system Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSLW4
In Commercial Distribution

  • 08436046001862 ()


  • Portable basic diagnostic x-ray system, digital

SEDECAL - 08436046001602

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-50HF-B-D-T
Not in Commercial Distribution

  • 08436046001602 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046001596

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-40HF-B-D-T
Not in Commercial Distribution

  • 08436046001596 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046001589

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-32HF-B-D-T
Not in Commercial Distribution

  • 08436046001589 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046001572

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-20HF-B-D-T
Not in Commercial Distribution

  • 08436046001572 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046001503

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-32HF-B-D-C
In Commercial Distribution

  • 08436046001503 ()


  • Mobile basic diagnostic x-ray system, digital

SEDECAL - 08436046001497

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-20HF-B-D-C
In Commercial Distribution

  • 08436046001497 ()


  • Mobile basic diagnostic x-ray system, digital
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