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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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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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-C
In Commercial Distribution

  • 08436046001510 ()


  • 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-C
In Commercial Distribution

  • 08436046001503 ()


  • 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-C
In Commercial Distribution

  • 08436046001497 ()


  • 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-Batt
In Commercial Distribution

  • 08436046001466 ()


  • 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
MILLENIUM PLUS TPC
In Commercial Distribution

  • 08436046001176 ()


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

  • 08436046001121 ()


  • 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-Batt
In Commercial Distribution

  • 08436046001114 ()


  • 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-Batt
In Commercial Distribution

  • 08436046001091 ()


  • Mobile basic diagnostic x-ray system, digital
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