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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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SOTA Cloud Imaging - 00860013687632

Dental Cloud Imaging Software
Sota Cloud Corp.
1
In Commercial Distribution

  • 00860013687632 ()


  • General-purpose dental x-ray system application software

TigerView - 00851800007108

TigerView software version 8.4.1
TELEVERE SYSTEMS, LLC
8.4.1
In Commercial Distribution

  • 00851800007108 ()
TigerView 8.4.1

  • 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

TigerView - 00851800007085

TigerView software version 8.2
TELEVERE SYSTEMS, LLC
8.2
In Commercial Distribution

  • 00851800007085 ()
TigerView 8.2

  • 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 - 00851800007061

TigerView software version 8.3
TELEVERE SYSTEMS, LLC
8.3
In Commercial Distribution

  • 00851800007061 ()
TigerView 8.3

  • 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

Visix - 00851800007030

Visix software version 2.3.9
TELEVERE SYSTEMS, LLC
2.3.9
In Commercial Distribution

  • 00851800007030 ()
Visix 2.3.9

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

SOTA Cloud Imaging - 00851159007125

Dental Cloud Imaging Software
SOTA PRECISION OPTICS, INC.
1
In Commercial Distribution

  • 00851159007125 ()


  • General-purpose dental x-ray system application software

Sleep Profiler - 00851113007024

Sleep Profiler Portal Software
ADVANCED BRAIN MONITORING, INC.
Sleep Profiler Portal Software
In Commercial Distribution

  • 00851113007024 ()


  • Polysomnography analyser

Sleep Profiler - 00851113007017

Sleep Profiler Desktop Software
ADVANCED BRAIN MONITORING, INC.
Sleep Profiler Desktop Software
In Commercial Distribution

  • 00851113007017 ()


  • Polysomnography analyser

IMPAX - 05400874000727

IMPAX Software 6.X
Agfa HealthCare NV
6
In Commercial Distribution



  • Radiological PACS software

PlanIQ - 05060608880874

Radiation therapy QA software.
SUN NUCLEAR CORP.
1216028
In Commercial Distribution

1216028

  • Radiation therapy software
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