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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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FDR Clinica - 08800011121303

480V3~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-32S
In Commercial Distribution

  • 08800011121303 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121280

380V3~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-32S
In Commercial Distribution

  • 08800011121280 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120511

220-230V/125kV
DRGEM Corporation
FDR Smart FGXR-C52S
In Commercial Distribution

  • 08800011120511 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120498

220-230V/125kV
DRGEM Corporation
FDR Smart FGXR-C40S
In Commercial Distribution

  • 08800011120498 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120474

220-230V/125kV
DRGEM Corporation
FDR Smart FGXR-C32S
In Commercial Distribution

  • 08800011120474 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120443

400V3~/150kV
DRGEM Corporation
FDR Smart FGXR-82S
In Commercial Distribution

  • 08800011120443 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120436

480V3~/150kV
DRGEM Corporation
FDR Smart FGXR-68S
In Commercial Distribution

  • 08800011120436 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120306

220-230V~ / 125kV
DRGEM Corporation
GXR-C52S
In Commercial Distribution

  • 08800011120306 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120290

110-120V~ / 150kV
DRGEM Corporation
GXR-C52S
In Commercial Distribution

  • 08800011120290 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120146

480V3~ / 125kV
DRGEM Corporation
GXR-32S
In Commercial Distribution

  • 08800011120146 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120139

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

  • 08800011120139 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120122

400V3~ / 125kV
DRGEM Corporation
GXR-32S
In Commercial Distribution

  • 08800011120122 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120115

100-240V~ / 125kV
DRGEM Corporation
GXR-U40S
In Commercial Distribution

  • 08800011120115 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120108

100-240V~ / 125kV
DRGEM Corporation
GXR-U32S
In Commercial Distribution

  • 08800011120108 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120092

110-120V~ / 125kV
DRGEM Corporation
GXR-C52S
In Commercial Distribution

  • 08800011120092 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120085

110-120V~ / 125kV
DRGEM Corporation
GXR-C40S
In Commercial Distribution

  • 08800011120085 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120078

110-120V~ / 125kV
DRGEM Corporation
GXR-C32S
In Commercial Distribution

  • 08800011120078 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120061

400V3~ / 150kV
DRGEM Corporation
GXR-82S
In Commercial Distribution

  • 08800011120061 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120054

400V3~ / 150kV
DRGEM Corporation
GXR-68S
In Commercial Distribution

  • 08800011120054 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120047

400V3~ / 150kV
DRGEM Corporation
GXR-52S
In Commercial Distribution

  • 08800011120047 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120030

220-230V~ / 150kV
DRGEM Corporation
GXR-40S
In Commercial Distribution

  • 08800011120030 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120023

220-230V~ / 125kV
DRGEM Corporation
GXR-40S
In Commercial Distribution

  • 08800011120023 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120016

220-230V~ / 150kV
DRGEM Corporation
GXR-32S
In Commercial Distribution

  • 08800011120016 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120009

220-230V~ / 125kV
DRGEM Corporation
GXR-32S
In Commercial Distribution

  • 08800011120009 ()


  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046001909

The SEDECAL X BRS (BRX) 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
SEDECAL X BRS (BRX)
In Commercial Distribution

  • 08436046001909 ()


  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046001855

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
SPSL-HF-8.0-APR
In Commercial Distribution

  • 08436046001855 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001848

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
SPSL-HF-4.0-APR
In Commercial Distribution

  • 08436046001848 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001831

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
SPSL-HF-8.0
In Commercial Distribution

  • 08436046001831 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001824

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
SPSL-HF-4.0
In Commercial Distribution

  • 08436046001824 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001794

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
SPL-HF-8.0
In Commercial Distribution

  • 08436046001794 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001787

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
SPL-HF-4.0
In Commercial Distribution

  • 08436046001787 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001770

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
SPL-HF-2.0
In Commercial Distribution

  • 08436046001770 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046000933

The SEDECAL X (URS) 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
SEDECAL X (URS)
In Commercial Distribution

  • 08436046000933 ()


  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046002500

The SEDECAL X URS 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
SEDECAL X URS
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046001923

This 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
MULTIRAD NET
In Commercial Distribution

  • 08436046001923 ()


  • Stationary basic diagnostic x-ray system, analogue

VisionX - E247E7300A10

VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software

VisionX - E247E7300

Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300 ()


  • General-purpose dental x-ray system application software

DBSWIN - E247E7200A0

Dental Imaging Software. Software Version 5.x.x.
DÜRR DENTAL SE
E7200A
Not in Commercial Distribution

  • E247E7200A0 ()


  • General-purpose dental x-ray system application software

DBSWIN 5.11.0 - E247E72000

No Description
DÜRR DENTAL SE
E7200
Not in Commercial Distribution

  • E247E72000 ()


  • General-purpose dental x-ray system application software

Monarch™ Software Laptop v2.1.5 - B634SW0032760201050

Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software

Monarch Software Laptop v2.2.1 - B634SW0121940202000

Monarch Software Laptop v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121940202000 ()


  • CT system application software

Monarch Software Laptop v2.1.6 - B634SW0121900201060

Monarch Software Laptop v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121900201060 ()


  • CT system application software

Monarch™ Software Laptop v2.1.4 - B634SW0032760201040

Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032760201040 ()


  • CT system application software

Monarch™ Software Laptop v2.1.3 - B634SW0032760201030

Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032760201030 ()


  • CT system application software

Monarch™ Software Laptop v2.1.2 - B634SW0032760201020

Monarch™ Software Laptop v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032760201020 ()


  • CT system application software

XDR - D787XDRSW300

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software

XDR - D787XDRSW1

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software

vascuCAP - B745VASCUCAPA2

No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution

  • B745VASCUCAPA2 ()


  • CT system application software

ElucidVivo - B745ELUCIDVIVOA3

No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution

  • B745ELUCIDVIVOA3 ()


  • CT system application software

vascuCAP - B745A40

No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution

  • B745A40 ()


  • CT system application software
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