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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400V3~ / 150kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140199 ()


  • Stationary basic diagnostic x-ray system, digital
400V3~ / 125kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140182 ()


  • Stationary basic diagnostic x-ray system, digital
100-240V~ / 125kV
DRGEM Corporation
GXR-U40SD
In Commercial Distribution

  • 08800011140144 ()


  • Stationary basic diagnostic x-ray system, digital
100-240V~ / 125kV
DRGEM Corporation
GXR-U32SD
In Commercial Distribution

  • 08800011140137 ()


  • Stationary basic diagnostic x-ray system, digital
110-120V~ / 125kV
DRGEM Corporation
GXR-C52SD
In Commercial Distribution

  • 08800011140120 ()


  • Stationary basic diagnostic x-ray system, digital
110-120V~ / 125kV
DRGEM Corporation
GXR-C40SD
In Commercial Distribution

  • 08800011140113 ()


  • Stationary basic diagnostic x-ray system, digital
110-120V~ / 125kV
DRGEM Corporation
GXR-C32SD
In Commercial Distribution

  • 08800011140106 ()


  • Stationary basic diagnostic x-ray system, digital
400V3~ / 150kV
DRGEM Corporation
GXR-82SD
In Commercial Distribution

  • 08800011140090 ()


  • Stationary basic diagnostic x-ray system, digital
400V3~ / 150kV
DRGEM Corporation
GXR-68SD
In Commercial Distribution

  • 08800011140083 ()


  • Stationary basic diagnostic x-ray system, digital
400V3~ / 150kV
DRGEM Corporation
GXR-52SD
In Commercial Distribution

  • 08800011140076 ()


  • Stationary basic diagnostic x-ray system, digital
220-230V~ / 150kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140069 ()


  • Stationary basic diagnostic x-ray system, digital
220-230V~ / 125kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140052 ()


  • Stationary basic diagnostic x-ray system, digital
220-230V~ / 150kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140045 ()


  • Stationary basic diagnostic x-ray system, digital
220-230V~ / 125kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140038 ()


  • Stationary basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 00935712300004 ()
MXU-RV01

  • Mobile basic diagnostic x-ray system, digital
MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
STEPHANIX
MOVIX DReamy_1050
In Commercial Distribution

  • 03664049902496 ()


  • Mobile basic diagnostic x-ray system, digital
MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
STEPHANIX
MOVIX DReamy_1040
In Commercial Distribution

  • 03664049902489 ()


  • Mobile basic diagnostic x-ray system, digital
MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
STEPHANIX
MOVIX DReamy_1032
In Commercial Distribution

  • 03664049902472 ()


  • Mobile basic diagnostic x-ray system, digital
MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
STEPHANIX
MOVIX DReamy_1020
In Commercial Distribution

  • 03664049902366 ()


  • 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

  • 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
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