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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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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
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