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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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Roentgen Works - 00850631008261

Roentgen Works 4.1.3 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.1.3
In Commercial Distribution

  • 00850631008261 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008254

Roentgen Works 4.1.2
Brit Systems, LLC
4.1.2
In Commercial Distribution

  • 00850631008254 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008735

Roentgen Works 6.6.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.6.0
In Commercial Distribution

  • 00850631008735 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

TruPlan - 00882916000530

No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution

  • 00882916000530 ()


  • CT system application software

TruPlan - 00882916000523

No Description
Circle Cardiovascular Imaging Inc
2.1
In Commercial Distribution

  • 00882916000523 ()


  • CT system application software

TruPlan - 00882916000516

No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution

  • 00882916000516 ()
v1.x and v2.0

  • CT system application software

mfiVerse - 00860059002109

No Description
MULTIFUNCTIONAL IMAGING, LLC
v1
In Commercial Distribution

  • 00860059002109 ()


  • PET system application software

Proteus Digital Health Feedback System - 00856602005222

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2330
In Commercial Distribution

  • 00856602005222 ()


  • Medication adherence telemetric monitoring system, post-ingestion

Proteus Digital Health Feedback System - 00856602005215

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2329
In Commercial Distribution

  • 00856602005215 ()


  • Medication adherence telemetric monitoring system, post-ingestion

Proteus Digital Health Feedback System - 00856602005130

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2005
In Commercial Distribution

  • 10856602005137 ()
  • 00856602005130 ()
  • 20856602005134 ()


  • Medication adherence telemetric monitoring system, post-ingestion
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