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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Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0072
In Commercial Distribution

  • 07350008750012 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
NANO-X IMAGING LTD
2.2.
In Commercial Distribution

  • 07290018465004 ()


  • Multi-directional tomography x-ray system
Digital Radiographic System
Imaging Dynamics Company Ltd
2200 X4C
In Commercial Distribution

  • 00823073061018 ()

  • Area/Surface Area: 46000 Square centimeter
  • Stand and Detector Head
  • Weight: 147 Kilogram
  • Height: 207 Centimeter
  • Table top surface area
  • Weight: 267 Kilogram
  • Table excluding Detector Head


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
2200 X3C
In Commercial Distribution

  • 00823073051027 ()

  • Weight: 267 Kilogram
  • Height: 207 Centimeter
  • Area/Surface Area: 46000 Square centimeter
  • Weight: 147 Kilogram
  • Table top surface area
  • Table excluding Detector Head
  • Stand and Detector Head


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1600 X4C
In Commercial Distribution

  • 00823073051010 ()

  • Weight: 324 Kilogram
  • Length: 2450 Millimeter
  • Length of the Column
  • Width: 1550 Millimeter
  • Width of the Column
  • Height of the Column
  • Weight of the Column
  • Height: 2645 Millimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1600 X3C
In Commercial Distribution

  • 00823073041028 ()

  • Width of the Column
  • Height of the Column
  • Weight of the Column
  • Height: 2645 Millimeter
  • Length: 2450 Millimeter
  • Weight: 324 Kilogram
  • Length of the Column
  • Width: 1550 Millimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1600 X4C
In Commercial Distribution

  • 00823073041011 ()

  • Height: 2645 Millimeter
  • Length: 2450 Millimeter
  • Weight: 324 Kilogram
  • Weight of the Column
  • Length of the Column
  • Width: 1550 Millimeter
  • Height of the Column
  • Width of the Column


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1600 X3C
In Commercial Distribution

  • 00823073031029 ()

  • Width of the Column
  • Height: 2645 Millimeter
  • Length of the Column
  • Width: 1550 Millimeter
  • Height of the Column
  • Length: 2450 Millimeter
  • Weight of the Column
  • Weight: 324 Kilogram


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1590 X4C
In Commercial Distribution

  • 00823073031012 ()

  • Stand and Detector Head
  • Weight: 267 Kilogram
  • Height: 207 Centimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1590 X3C
In Commercial Distribution

  • 00823073021020 ()

  • Stand and Detector Head
  • Weight: 267 Kilogram
  • Height: 207 Centimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1500 X4C
In Commercial Distribution

  • 00823073021013 ()

  • Stand and Detector Head
  • Weight: 260 Kilogram
  • Height: 212 Centimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1100 X3C
In Commercial Distribution

  • 00823073011021 ()

  • Weight of Table and Detector Head
  • Table Dimensions
  • Height: 93 Centimeter
  • Width: 85.3 Centimeter
  • Length: 240 Centimeter
  • Weight: 233 Kilogram


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1100 X4C
In Commercial Distribution

  • 00823073011014 ()

  • Height: 93 Centimeter
  • Width: 85.3 Centimeter
  • Weight of Table and Detector Head
  • Table Dimensions
  • Length: 240 Centimeter
  • Weight: 233 Kilogram


  • Stationary basic diagnostic x-ray system, digital
THL 3543EZ CsI Digital Wireless Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN280
In Commercial Distribution

  • 00817100020285 ()


  • Diagnostic x-ray digital imaging conversion system
X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1800 X4C
In Commercial Distribution

  • 00823073061019 ()

  • Height: 244 Centimeter
  • Stand and Detector Head
  • Weight: 875 Kilogram


  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution

  • 00884838064751 ()
712214

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost Compact
Not in Commercial Distribution

  • 00884838064737 ()
712213

  • Stationary basic diagnostic x-ray system, digital
Antiseptic Skin Cleansing Kit with 2% Chlorhexidine Gluconate (CHG)
SAGE PRODUCTS, LLC
9101
In Commercial Distribution

  • 50618029850596 ()
  • 00618029850591 ()
9101

  • Dry medical towel/wipe, single-use
  • Skin cleaning wipe
FRAXEL FTX CONSOLE, NEXT GENERATION
SOLTA MEDICAL
MCSYSFTX
In Commercial Distribution

  • 00816995027805 ()
MCSYSFTX

  • Dermatological laser beam guiding handpiece
  • Dermatological solid-state laser system
REFURBISHED FRAXEL FTX CONSOLE, NEXT GENERATION
SOLTA MEDICAL
MCSYSFTX-R
In Commercial Distribution

  • 00816995027799 ()
MCSYSFTX-R

  • Dermatological solid-state laser system
  • Dermatological laser beam guiding handpiece
Iowa State Fixation Forceps, Flat Handle With Polished Finish, Straight Shafts, 1 X 2 Teeth, And Overall Length Of 3 3/8" (86mm)
Med Saver, Inc.
5-2835
In Commercial Distribution

  • 00194613006624 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation
No Description
CANON INC.
CSX-30
In Commercial Distribution

  • 04549292075175 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
VAREX IMAGING CORPORATION
v4.9
In Commercial Distribution

  • 00854344007658 ()


  • Angiographic x-ray system application software
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.6
In Commercial Distribution

  • 00854344007610 ()


  • X-ray system computer, diagnostic, general-purpose
Nexus DRF v3.1.2
VAREX IMAGING CORPORATION
v3.1.2
In Commercial Distribution

  • 00854344007474 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.2.0
In Commercial Distribution

  • 00854344007443 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.1.0
In Commercial Distribution

  • 00854344007429 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v3.0.0
In Commercial Distribution

  • 00854344007276 ()


  • X-ray system computer, diagnostic, general-purpose
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