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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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Orthosoft Inc
305.1004
Not in Commercial Distribution

  • 00889024211612 ()
305.1004

  • CAD/CAM software
LIFESYS PACS v2
LIFETRACK MEDICAL SYSTEMS INC.
2
In Commercial Distribution

  • B581LIFESYSPACSV20 ()


  • Radiological PACS software
AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: • Manual annotation tools for users to select regions of interest (ROIs), • Semi-automatic lesion segmentation suggestions for user-selected ROIs, • Automatic measurement and display of long and short axis of segmented lesions, • Automatic tabulation and summation of measurements, • Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), • Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and • Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.
Ai Metrics, LLC
1
In Commercial Distribution

  • G090AIM11 ()
AIM1

  • 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
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
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