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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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NA - 08806088565231

The GC85A 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.
GC85A
In Commercial Distribution

  • 08806088565231 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088520971

The GU60A-65 Digital X-ray Imaging Systems are 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.
GU60A-65
In Commercial Distribution

  • 08806088520971 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088351889

The GF50A 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.
GF50A
In Commercial Distribution

  • 08806088351889 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088351872

The GF50 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.
GF50
In Commercial Distribution

  • 08806088351872 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806086403467

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

Definium - 00840682104364

No Description
GE MEDICAL SYSTEMS, INC.
5000
In Commercial Distribution

  • 00840682104364 ()


  • Stationary basic diagnostic x-ray system, digital

Optima - 00840682142168

XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00840682142168 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00840682141932

G3 Standard Table
GE Hualun Medical Systems Co., Ltd
6788888-2
In Commercial Distribution

  • 00840682141932 ()


  • Stationary basic diagnostic x-ray system, digital

BIOK-4600 - 10862318000311

Digital X-Ray Sensor
BIOKINEMETRICS, INC.
IMA-4600
In Commercial Distribution

  • 10862318000311 ()


  • Stationary basic diagnostic x-ray system, digital

Discovery - 00840682146210

XR656 G1 SYS-CABINET WSO
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682146210 ()


  • Stationary basic diagnostic x-ray system, digital
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