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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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3D diagnosis and communication module
3DIEMME SRL
RealGUIDE START
In Commercial Distribution

  • 08050038830034 ()


  • CAD/CAM software
Surgical guides modelling
3DIEMME SRL
RealGUIDE DESIGN
In Commercial Distribution

  • 08050038830027 ()


  • CAD/CAM software
Implants planning
3DIEMME SRL
RealGUIDE PRO
In Commercial Distribution

  • 08050038830010 ()


  • CAD/CAM software
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
VARIAN MEDICAL SYSTEMS, INC.
3.1
In Commercial Distribution

  • 00899475002608 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.2
In Commercial Distribution

  • 00899475002462 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00899475002431 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002424 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002417 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002400 ()


  • Radiation therapy software
Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud.
SONOMED, INC.
Ver 5
In Commercial Distribution

  • 00896100002002 ()
Axis

  • Ophthalmology PACS software
Ophthalmic Photography
OPHTHALMIC LABS INC
5.0
In Commercial Distribution

  • G62650 ()


  • Camera application 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 2.1
Not in Commercial Distribution

  • 03700719700013 ()


  • Radiological PACS software
The Theraview software is used in radiation therapy clinics to acquire Megavoltage (MV) and/ or kiloVoltage (kV) images by means of an imaging device, using one of the Cablon Medical accessories EPID, DAR, eDAR or TBI, and perform image registration (i.e. image matching, tracking) or import match results, in order to accurately set up and position patients for treatment
Cablon Medical B.V.
C01-01-00
In Commercial Distribution

  • 08717953004000 ()
C01-01-00

  • Radiation therapy 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
Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170538-00
In Commercial Distribution

  • 08717213053717 ()


  • Radiation therapy software
Oncentra External Beam Oncentra Brachy v4.6.1
Nucletron B.V.
170607-00
In Commercial Distribution

  • 08717213052758 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-08
In Commercial Distribution

  • 08717213052321 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-28
In Commercial Distribution

  • 08717213052314 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052307 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-27
Not in Commercial Distribution

  • 08717213052291 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052246 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-25
Not in Commercial Distribution

  • 08717213052239 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213020610 ()


  • Radiation therapy software
Oncentra External Beam v4.5
Nucletron B.V.
Oncentra External Beam
In Commercial Distribution

  • 08717213038677 ()


  • Radiation therapy software
Oncentra Brachy v4.5
Nucletron B.V.
Oncentra Brachy
In Commercial Distribution

  • 08717213038660 ()


  • Radiation therapy software
Oncentra Prostate v4.2 (including Oncentra Seeds)
Nucletron B.V.
Oncentra Prostate including Oncentra Seeds
In Commercial Distribution

  • 08717213037861 ()


  • Radiation therapy 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
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