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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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Smart Segmentation Knowledge Based Contouring - 00856100006059

No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1
In Commercial Distribution

  • 00856100006059 ()


  • Radiation therapy software

Smart Segmentation - Knowledge Based Contouring - 00856100006011

No Description
Varian Medical Systems Imaging Laboratory GmbH
15.0
In Commercial Distribution

  • 00856100006011 ()


  • Radiation therapy software

DigiView - 00857050006038

Doctor's Reading Station
Digisonics Inc
4.0
In Commercial Distribution

  • 00857050006038 ()


  • Radiological PACS software

OBView - 00857050006021

System, Image Processing, Radiological - Doctors Reading Station
Digisonics Inc
4.9
In Commercial Distribution

  • 00857050006021 ()


  • Radiological PACS software

OBView - 00857050006014

System, Image Processing, Radiological - Doctors reading Station
Digisonics Inc
4.8
In Commercial Distribution

  • 00857050006014 ()


  • Radiological PACS software

DigiView - 00857050006007

Doctors Review Station - System, Image processing, Radiological
Digisonics Inc
3.8
In Commercial Distribution

  • 00857050006007 ()


  • Radiological PACS software

HealthView CardioPACS - 00857560008003

CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms.
LUMEDX CORPORATION
6.4.3
In Commercial Distribution

  • 00857560008003 ()
113-00749

  • Radiological PACS software

Eclipse Treatment Planning System - 00855141006349

No Description
VARIAN MEDICAL SYSTEMS, INC.
18.1
In Commercial Distribution

  • 00855141006349 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006202

No Description
VARIAN MEDICAL SYSTEMS, INC.
18.0
In Commercial Distribution

  • 00855141006202 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006103

No Description
VARIAN MEDICAL SYSTEMS, INC.
17.0
In Commercial Distribution

  • 00855141006103 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006080

No Description
VARIAN MEDICAL SYSTEMS, INC.
16.1
In Commercial Distribution

  • 00855141006080 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006073

No Description
VARIAN MEDICAL SYSTEMS, INC.
16.0
In Commercial Distribution

  • 00855141006073 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006066

No Description
Varian Medical Systems Finland Oy
15.6
In Commercial Distribution

  • 00855141006066 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006059

No Description
Varian Medical Systems Finland Oy
15.5
In Commercial Distribution

  • 00855141006059 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006042

No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1.1
In Commercial Distribution

  • 00855141006042 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006035

No Description
VARIAN MEDICAL SYSTEMS, INC.
13.6
In Commercial Distribution

  • 00855141006035 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006028

No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1
In Commercial Distribution

  • 00855141006028 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006011

No Description
Varian Medical Systems Finland Oy
15.0
In Commercial Distribution

  • 00855141006011 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006004

No Description
Varian Medical Systems Finland Oy
13.7
In Commercial Distribution

  • 00855141006004 ()


  • Radiation therapy software

DENTCA Design - 00856551007513

DENTCA Design - Pala Design Studio
DENTCA, INC.
DENTCA Design - Pala Design Studio
In Commercial Distribution

  • 00856551007513 ()


  • CAD/CAM software

DENTCA Design - 00856551007292

DENTCA Design - NGuard
DENTCA, INC.
DENTCA Design - NGuard
In Commercial Distribution

  • 00856551007292 ()


  • CAD/CAM software

DENTCA Design - 00856551007285

DENTCA Design-Dentru
DENTCA, INC.
DENTCA Design-Dentru
In Commercial Distribution

  • 00856551007285 ()


  • CAD/CAM software

Synthesis Vision Viewer - 75401622502202

No Description
Synthesis Health Intelligence Inc
2.0
In Commercial Distribution

  • 75401622502202 ()


  • Radiological PACS software

Vitesee - 00850800006074

No Description
VARIAN MEDICAL SYSTEMS, INC.
5.0
In Commercial Distribution

  • 00850800006074 ()


  • Radiation therapy software

VariSeed - 00850800006067

No Description
VARIAN MEDICAL SYSTEMS, INC.
10.0
In Commercial Distribution

  • 00850800006067 ()


  • Radiation therapy software

Mobius3D - 00850800006050

No Description
VARIAN MEDICAL SYSTEMS, INC.
4.1
In Commercial Distribution

  • 00850800006050 ()


  • Radiation therapy software

Mobius3D - 00850800006043

No Description
VARIAN MEDICAL SYSTEMS, INC.
4.0
In Commercial Distribution

  • 00850800006043 ()


  • Radiation therapy software

Vitesse - 00850800006012

No Description
VARIAN MEDICAL SYSTEMS, INC.
4.0
In Commercial Distribution

  • 00850800006012 ()


  • Radiation therapy software

VariSeed 9.0 - 00850800006005

No Description
VARIAN MEDICAL SYSTEMS, INC.
9.0
In Commercial Distribution

  • 00850800006005 ()


  • 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

GearView Basic - 00850677007341

No Description
HYLAND LLC
3X
In Commercial Distribution

  • 00850677007341 ()
  • 00850677007358 ()


  • Radiological PACS software

GearView QC - 00850677007327

No Description
HYLAND LLC
3X
In Commercial Distribution

  • 00850677007334 ()
  • 00850677007327 ()
  • 00850677007051 ()


  • Radiological PACS software

EHR-Gateway Print - 00850677007310

No Description
HYLAND LLC
2.X
Not in Commercial Distribution

  • 00850677007310 ()


  • Radiological PACS software

Image Link Encounter Workflow - 00850677007303

Encounter Manager
HYLAND LLC
2.X
Not in Commercial Distribution

  • 00850677007303 ()


  • Radiological PACS software

Image Link - 00850677007297

No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007297 ()


  • Radiological PACS software

PACS Scan Web - 00850677007280

No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007280 ()


  • Radiological PACS software

ModLink Web Forms - 00850677007273

Web Forms
HYLAND LLC
4.X
Not in Commercial Distribution

  • 00850677007273 ()


  • Radiological PACS software

EHR-Gateway - 00850677007266

No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007266 ()


  • Radiological PACS software

PACSgear Enterprise Server - 00850677007259

Core Server
HYLAND LLC
5.X
Not in Commercial Distribution

  • 00850677007259 ()


  • Radiological PACS software

PACSgear Media Writer Web - 00850677007242

Media Writer Web
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007242 ()


  • Radiological PACS software

PACSgear EHR Gateway - 00850677007235

EHR Gateway
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007235 ()


  • Radiological PACS software

PACSgear Web Forms - 00850677007228

Web Forms, Mod Link Web Forms
HYLAND LLC
3.X
In Commercial Distribution

  • 00850677007228 ()


  • Radiological PACS software

PACSgear Mod Link - 00850677007211

Mod LInk
HYLAND LLC
3.X
In Commercial Distribution

  • 00850677007211 ()


  • Radiological PACS software

PACSgear Image Link Encounter Workflow - 00850677007204

Image Link Encounter Workflow
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007204 ()


  • Radiological PACS software

PACSgear Image Link - 00850677007198

Image Link
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007198 ()


  • Radiological PACS software

PACSgear PACS Scan Web - 00850677007181

PACS Scan Web
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007181 ()


  • Radiological PACS software

PACS Scan Mobile - 00850677007150

PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software

GEAR VIEW QC CD - 00850677007105

GEAR VIEW QC CD
HYLAND LLC
2
In Commercial Distribution

  • 00850677007105 ()


  • Radiological PACS software
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