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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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Grin App -W - D962GGAW0002

No Description
Get-Grin Inc.
W Version
In Commercial Distribution

  • D962GGAW0002 ()


  • Radiological PACS software

Grin Records App - D962GGAR0003

No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGAR0003 ()


  • Radiological PACS software

Grin App - D962GGA00001

No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software

Mimics Flow - 05404028000908

Mimics Flow
Materialise NV
Mimics Flow
In Commercial Distribution

  • 05404028000908 ()
Mimics Flow

  • CAD/CAM software

Mimics Flow - 05404028000632

Mimics Flow
Materialise NV
Mimics Flow
In Commercial Distribution

  • 05404028000632 ()
Mimics Flow

  • CAD/CAM software

SurgiCase OOS - 05404028000281

SurgiCase Mobile
Materialise NV
SurgiCase Mobile
In Commercial Distribution

  • 05404028000281 ()
SurgiCase Mobile

  • CAD/CAM software

Aqua - 00858164002381

No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software

PACSgear Enterprise Server - 00850677007419

PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.
HYLAND LLC
5.2.X
In Commercial Distribution

  • 00850677007419 ()
CS.5.2

  • Radiological PACS software

PACSgear Enterprise Server - 00850677007396

PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client configuration, and the flow of data between modalities and destination DICOM systems. PACSgear
HYLAND LLC
5.1.X
In Commercial Distribution



  • Radiological PACS software

Image Link Plus - 00850677007389

Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007389 ()


  • Radiological PACS software
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