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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GE HEALTHCARE
CPACS 7.0
In Commercial Distribution

  • 00840682145558 ()


  • Radiological PACS software
Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use.
INTRASENSE
MYRIAN 2.9
In Commercial Distribution

  • 03700719700471 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.7.6
Not in Commercial Distribution

  • 03700719700464 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.8
In Commercial Distribution

  • 03700719700457 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.7
In Commercial Distribution

  • 03700719700440 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.6
In Commercial Distribution

  • 03700719700433 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.5
In Commercial Distribution

  • 03700719700426 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.4
Not in Commercial Distribution

  • 03700719700419 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.3
Not in Commercial Distribution

  • 03700719700402 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.2
Not in Commercial Distribution

  • 03700719700396 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.1
Not in Commercial Distribution

  • 03700719700013 ()


  • Radiological PACS software
QuantX is a software program that is used to view and analyze patient breast images.
QLARITY IMAGING, LLC
Breast MRI SE
Not in Commercial Distribution

  • B80731 ()
3

  • Radiological PACS software
The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution

  • B80721 ()
2

  • Radiological PACS software
QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution

  • B80711 ()
1

  • Radiological PACS software
ACO Planner
Materialise NV
ACO Planner
Not in Commercial Distribution

  • E314ACOPLANNER0 ()
ACO Planner

  • CAD/CAM software
Zimmer PSIP
Materialise NV
Zimmer PSIP
Not in Commercial Distribution

  • E314ZIMMERPSIP0 ()
Zimmer PSIP

  • CAD/CAM software
Zimmer online management system
Materialise NV
Zimmer online management system
Not in Commercial Distribution

  • E314ZIMMERPSIOMS0 ()
Zimmer online management system

  • CAD/CAM software
SurgiCase Viewer
Materialise NV
SurgiCase Viewer
In Commercial Distribution

  • E314SURGICASEVIEWER0 ()
SurgiCase Viewer

  • CAD/CAM software
SurgiCase Transfer
Materialise NV
SurgiCase Transfer
In Commercial Distribution

  • E314SURGICASETRANSFER0 ()
SurgiCase Transfer

  • CAD/CAM software
SurgiCase Shoulder Planner
Materialise NV
SurgiCase Shoulder Planner
In Commercial Distribution

  • E314SURGICASESHOULPLAN0 ()
SurgiCase Shoulder Planner

  • CAD/CAM software
SurgiCase Planner
Materialise NV
SurgiCase Planner
Not in Commercial Distribution

  • E314SURGICASEPLANNER0 ()
SurgiCase Planner

  • CAD/CAM software
SurgiCase OOS
Materialise NV
SurgiCase OOS
In Commercial Distribution

  • E314SURGICASEOOS0 ()
SurgiCase OOS

  • CAD/CAM software
SurgiCase Online
Materialise NV
SurgiCase Online
In Commercial Distribution

  • E314SURGICASEONLINE0 ()
SurgiCase Online

  • CAD/CAM software
SurgiCase Knee Planner
Materialise NV
SurgiCase Knee Planner
In Commercial Distribution

  • E314SURGICASEKNEEPLAN0 ()
SurgiCase Knee Planner

  • CAD/CAM software
SurgiCase Connect (iPad)
Materialise NV
SurgiCase Connect
Not in Commercial Distribution

  • E314SURGICASECONNECTIP0 ()
SurgiCase Connect

  • CAD/CAM software
SurgiCase Connect
Materialise NV
SurgiCase Connect
Not in Commercial Distribution

  • E314SURGICASECONNECT0 ()
SurgiCase Connect

  • CAD/CAM software
SurgiCase CMF
Materialise NV
SurgiCase CMF
Not in Commercial Distribution

  • E314SURGICASECMF0 ()
SurgiCase CMF

  • CAD/CAM software
Signature online management system
Materialise NV
Signature online management system
Not in Commercial Distribution

  • E314SIGNATUREOMS0 ()
Signature online management system

  • CAD/CAM software
Signature Planner
Materialise NV
Signature Planner
Not in Commercial Distribution

  • E314SIGNATURE0 ()
Signature Planner

  • CAD/CAM software
ProPlan CMF Online
Materialise NV
ProPlan CMF Online
In Commercial Distribution

  • E314PROPLANCMFONLINE0 ()
ProPlan CMF Online

  • CAD/CAM software
ProPlan CMF Connect
Materialise NV
ProPlan CMF Connect
Not in Commercial Distribution

  • E314PROPLANCMFCONNECT0 ()
ProPlan CMF Connect

  • CAD/CAM software
ProPlan CMF
Materialise NV
ProPlan CMF
In Commercial Distribution

  • E314PROPLANCMF0 ()
ProPlan CMF

  • CAD/CAM software
Mimics Medical
Materialise NV
Mimics Medical
In Commercial Distribution

  • E314MIMICSMEDICAL0 ()
Mimics Medical

  • CAD/CAM software
Mimics inPrint
Materialise NV
Mimics inPrint
In Commercial Distribution

  • E314MIMICSINPRINT0 ()
Mimics inPrint

  • CAD/CAM software
Mimics Enlight Medical
Materialise NV
Mimics Enlight Medical
In Commercial Distribution

  • E314MIMICSENLIGHTMED0 ()
Mimics Enlight Medical

  • CAD/CAM software
Mimics Automatic Algorithms Knee MRI
Materialise NV
Knee MRI
In Commercial Distribution

  • E314MIMICSAAKNEEMRI0 ()
Knee MRI

  • CAD/CAM software
Mimics Automatic Algorithms Knee CT
Materialise NV
Knee CT
In Commercial Distribution

  • E314MIMICSAAKNEECT0 ()
Knee CT

  • CAD/CAM software
Mimics Automatic Algorithms Heart CT
Materialise NV
Heart CT
In Commercial Distribution

  • E314MIMICSAAHEARTCT0 ()
Heart CT

  • CAD/CAM software
Mimics Automatic Algorithms CMF CT
Materialise NV
CMF CT
Not in Commercial Distribution

  • E314MIMICSAACMFCT0 ()
CMF CT

  • CAD/CAM software
3-matic Medical
Materialise NV
3-matic Medical
In Commercial Distribution

  • E3143MATICMEDICAL0 ()
3-matic Medical

  • CAD/CAM software
3-matic Medical
Materialise NV
3-matic Medical
Not in Commercial Distribution

  • E31433MATICMEDICAL0 ()
3-matic Medical

  • CAD/CAM software
Sidexis 4 (Update) 4.4
SIRONA Dental Systems GmbH
6775592
In Commercial Distribution

  • E27667755921 ()


  • Radiological PACS software
Sidexis 4 (Upgrade) 4.4
SIRONA Dental Systems GmbH
6775584
In Commercial Distribution

  • E27667755841 ()


  • Radiological PACS software
Sidexis 4 (Full version) 4.4
SIRONA Dental Systems GmbH
6773787
In Commercial Distribution

  • E27667737871 ()


  • Radiological PACS software
Sidexis 4 V4.4
SIRONA Dental Systems GmbH
6773258
In Commercial Distribution

  • E27667732580 ()


  • Radiological PACS software
CEREC AC 2.0 with Omnicam camera and touch pad
SIRONA Dental Systems GmbH
6667237
In Commercial Distribution

  • E27666672370 ()


  • CAD/CAM software
CEREC AC 2.0 with QCC camera and touch pad
SIRONA Dental Systems GmbH
6667211
In Commercial Distribution

  • E27666672110 ()


  • CAD/CAM software
Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6663277
In Commercial Distribution

  • E27666632770 ()


  • Radiological PACS software
Sidexis Update
SIRONA Dental Systems GmbH
6618263
In Commercial Distribution

  • E27666182630 ()


  • Radiological PACS software
Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6616465
In Commercial Distribution



  • Radiological PACS software
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