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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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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
The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
HDX WILL CORP.
Will3D
In Commercial Distribution

  • 08800005200144 ()


  • Radiological PACS software
No Description
Ray Co., Ltd
2.2.0.0
In Commercial Distribution

  • 08800003005031 ()


  • CAD/CAM software
No Description
DRGEM Corporation
GEMPACS
In Commercial Distribution

  • 08800011170028 ()


  • Radiological PACS 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
CEREC SW 4.4.1
SIRONA Dental Systems GmbH
6580265
In Commercial Distribution

  • E27665802650 ()


  • CAD/CAM software
CEREC Premium CAM SW 4.4.0
SIRONA Dental Systems GmbH
6574250
In Commercial Distribution

  • E27665742500 ()


  • CAD/CAM software
CEREC AF Connect with Omnicam
SIRONA Dental Systems GmbH
6564715
In Commercial Distribution

  • E27665647150 ()


  • CAD/CAM software
CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software
CEREC Ortho SW 1.1
SIRONA Dental Systems GmbH
6562107
Not in Commercial Distribution

  • E27665621070 ()


  • CAD/CAM software
inLab CAM 15.0
SIRONA Dental Systems GmbH
6553882
In Commercial Distribution

  • E27665538820 ()


  • CAD/CAM software
inLab SW 15.0
SIRONA Dental Systems GmbH
6553874
In Commercial Distribution

  • E27665538740 ()


  • CAD/CAM software
CEREC Premium SW 4.4.0
SIRONA Dental Systems GmbH
6553031
In Commercial Distribution

  • E27665530310 ()


  • CAD/CAM software
CEREC SW 4.4
SIRONA Dental Systems GmbH
6553023
In Commercial Distribution

  • E27665530230 ()


  • CAD/CAM software
inCoris PMMA guide disc 22
SIRONA Dental Systems GmbH
6551324
In Commercial Distribution

  • E27665513242 ()


  • CAD/CAM software
CEREC AI without CEREC Omnicam
SIRONA Dental Systems GmbH
6542901
In Commercial Distribution

  • E27665429010 ()


  • CAD/CAM software
CEREC AF without CEREC Omnicam
SIRONA Dental Systems GmbH
6542893
In Commercial Distribution

  • E27665428930 ()


  • CAD/CAM software
CEREC AI with CEREC Omnicam
SIRONA Dental Systems GmbH
6534791
In Commercial Distribution

  • E27665347910 ()


  • CAD/CAM software
CEREC AF with CEREC Omnicam
SIRONA Dental Systems GmbH
6532076
In Commercial Distribution

  • E27665320760 ()


  • CAD/CAM software
CEREC Guide Bloc medi
SIRONA Dental Systems GmbH
6466564
In Commercial Distribution

  • E27664665642 ()


  • CAD/CAM software
CEREC Guide Pilot Drill Keys 2.2
SIRONA Dental Systems GmbH
6462563
In Commercial Distribution

  • E27664625632 ()


  • CAD/CAM software
CEREC Guide Pilot Drill Keys 2.0
SIRONA Dental Systems GmbH
6462530
In Commercial Distribution

  • E27664625302 ()


  • CAD/CAM software
SIDEXIS 4 Basis-DVD
SIRONA Dental Systems GmbH
6456532
In Commercial Distribution

  • E27664565320 ()


  • Radiological PACS software
CEREC Guide Bloc maxi
SIRONA Dental Systems GmbH
6447093
In Commercial Distribution

  • E27664470932 ()


  • CAD/CAM software
CEREC AC Connect Omnicam
SIRONA Dental Systems GmbH
6431519
In Commercial Distribution

  • E27664315190 ()


  • CAD/CAM software
APOLLO DI
SIRONA Dental Systems GmbH
6418375
Not in Commercial Distribution

  • E27664183750 ()


  • CAD/CAM software
Cerec Guide Blocs L
SIRONA Dental Systems GmbH
6375070
Not in Commercial Distribution

  • E27663750702 ()


  • CAD/CAM software
Cerec Guide Blocs M
SIRONA Dental Systems GmbH
6375062
Not in Commercial Distribution

  • E27663750622 ()


  • CAD/CAM software
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