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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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ClearPoint Array - 00850376007871

ClearPoint Array Software Version 1.2
Clearpoint Neuro, Inc.
CPA-SFW-11-12
In Commercial Distribution

  • 00850376007871 ()
CPA-SFW-11-12

  • Neurological stereotactic surgery system

ClearPoint Array - 00850376007659

ClearPoint Array Software Version 1.1
Clearpoint Neuro, Inc.
CPA-SFW-11-11
In Commercial Distribution

  • 00850376007659 ()
CPA-SFW-11-11

  • Neurological stereotactic surgery system

ClearPoint Array - 00850359007744

ClearPoint Array Software Version 1.0
Clearpoint Neuro, Inc.
CPA-SFW-11-1
In Commercial Distribution

  • 00850359007744 ()
CPA-SFW-11-1

  • Neurological stereotactic surgery system

Affymetrix - 00856826006074

Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
1.2
In Commercial Distribution

  • 00856826006074 ()
610525

  • Human genomic analysis interpretive software

Applied Biosystems - 00856826006210

Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
2.1
In Commercial Distribution

  • 00856826006210 ()
610525

  • Human genomic analysis interpretive software

Not Applicable - 10195278901764

Software Pristina 9 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.9
In Commercial Distribution

  • 10195278901764 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

Visix - 00851800007054

Visix 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007054 ()
Visix 8.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software

Visix - 00851800007047

Visix Pro software version 7.7.15
TELEVERE SYSTEMS, LLC
7.7.15
In Commercial Distribution

  • 00851800007047 ()
Visix Pro 7.7.15

  • Basic diagnostic x-ray system application software
  • Camera application software
  • General-purpose dental x-ray system application software
  • Radiological PACS software

TigerView - 00851800007023

TigerView Pro software version 7.7.3
TELEVERE SYSTEMS, LLC
7.7.3
In Commercial Distribution

  • 00851800007023 ()
TigerView Pro 7.7.3

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software

TigerView - 00851800007016

TigerView 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007016 ()
TigerView 8.1 Build 81

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
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