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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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The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-40S
In Commercial Distribution

  • 08806088088266 ()


  • Mobile basic diagnostic x-ray system, digital
The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC80
In Commercial Distribution

  • 08806086403467 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-12700-32
In Commercial Distribution

  • 04540217060016 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-12700-22
In Commercial Distribution

  • 04540217059980 ()


  • Stationary basic diagnostic x-ray system, digital
Digital Medical X-ray Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i
In Commercial Distribution

  • 06971576833023 ()


  • Stationary basic diagnostic x-ray system, digital
The uDR 596i Radiographic system is intended to be used 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, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution

  • 00810030350002 ()


  • Stationary basic diagnostic x-ray system, analogue
Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0180
In Commercial Distribution

  • 07350008750050 ()


  • Stationary basic diagnostic x-ray system, digital
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
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