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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 - 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 - 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 - 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 - 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

DRX - Ascend System - 60889978604227

DRX-ASCEND SYSTEM/QG-50-4-R10-T140
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889978604227 ()
8604225

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

DRX - Ascend System - 60889978604210

DRX-ASCEND SYSTEM/QG-50-3-R10-T140
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889978604210 ()
8604217

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