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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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
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
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
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
ODYSSEY+
In Commercial Distribution

  • 08436046003729 ()
2450

  • Mobile basic diagnostic x-ray system, digital
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
ODYSSEY+
In Commercial Distribution

  • 08436046003712 ()
2440

  • Mobile basic diagnostic x-ray system, digital
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
ODYSSEY+
In Commercial Distribution

  • 08436046003705 ()
2432

  • Mobile basic diagnostic x-ray system, digital
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
ODYSSEY+
In Commercial Distribution

  • 08436046003699 ()
2420

  • Mobile basic diagnostic x-ray system, digital
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
ODYSSEY
In Commercial Distribution

  • 08436046003682 ()
2450

  • Mobile basic diagnostic x-ray system, digital
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
ODYSSEY
In Commercial Distribution

  • 08436046003675 ()
2440

  • Mobile basic diagnostic x-ray system, digital
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
ODYSSEY
In Commercial Distribution

  • 08436046003668 ()
2432

  • Mobile basic diagnostic x-ray system, digital
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
ODYSSEY
In Commercial Distribution

  • 08436046003651 ()
2420

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046003170 ()
4650

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046003163 ()
4640

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046003156 ()
4632

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046003149 ()
4620

  • Mobile basic diagnostic x-ray system, digital
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
AeroDR TX m01
In Commercial Distribution

  • 08436046003132 ()
3650

  • Mobile basic diagnostic x-ray system, digital
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
AeroDR TX m01
In Commercial Distribution

  • 08436046003125 ()
3640

  • Mobile basic diagnostic x-ray system, digital
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
AeroDR TX m01
In Commercial Distribution

  • 08436046003118 ()
3632

  • Mobile basic diagnostic x-ray system, digital
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
AeroDR TX m01
In Commercial Distribution

  • 08436046003101 ()
3620

  • Mobile basic diagnostic x-ray system, digital
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
In Commercial Distribution

  • 08436046003033 ()


  • Stationary basic diagnostic x-ray system, digital
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
In Commercial Distribution

  • 08436046003026 ()


  • Stationary basic diagnostic x-ray system, digital
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

  • 08436046003019 ()
4650

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046003002 ()
4640

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002999 ()
4632

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002982 ()
4620

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002975 ()
3650

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002968 ()
3640

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002951 ()
3632

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002944 ()
3620

  • Mobile basic diagnostic x-ray system, digital
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-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002609 ()


  • Mobile basic diagnostic x-ray system, digital
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-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002593 ()


  • Mobile basic diagnostic x-ray system, digital
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-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002586 ()


  • Mobile basic diagnostic x-ray system, digital
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-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002579 ()


  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002562 ()
10451-01

  • Mobile basic diagnostic x-ray system, digital
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

  • 08436046002555 ()
10451

  • Mobile basic diagnostic x-ray system, digital
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
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
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
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
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
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