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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No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
2.2
In Commercial Distribution

  • B720BX360ELUNG220 ()


  • X-ray image interpretive software
No Description
GENORAY CO., LTD.
Zenis
In Commercial Distribution

  • 08809244060137 ()


  • X-ray image interpretive software
The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
v4.8.0
In Commercial Distribution

  • 08908019450057 ()
NA

  • Infrared thermography interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.11
Not in Commercial Distribution

  • 09120105730471 ()
  • 09120105730464 ()


  • X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.05
Not in Commercial Distribution

  • 09120105730082 ()
  • 09120105730037 ()


  • X-ray image interpretive software
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology. IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
IB Lab GmbH
V1.06
In Commercial Distribution

  • 09120105730730 ()


  • X-ray image interpretive software
Critical Care Suite 2.0, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.0
In Commercial Distribution

  • 00195278217981 ()


  • X-ray image interpretive software
Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00195278789365 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.2
In Commercial Distribution

  • B720BX360TRIAGESTRO1120 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360TRIAGELVO1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360TRIAGEICH1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
2.1
In Commercial Distribution

  • B720BX360ELUNG210 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
1.0
In Commercial Distribution

  • B720BX360ELUNG100 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTP1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360ECTA1130 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTA1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360EASPECTS113 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EASPECTS1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EMRI1110 ()


  • X-ray image interpretive software
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
2.Y.Z
In Commercial Distribution

  • 08720387058051 ()


  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
2.Y.Z
In Commercial Distribution

  • 08720387058044 ()


  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
1.7.2
In Commercial Distribution

  • 08720387058013 ()


  • X-ray image interpretive software
StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients.
NICo-Lab B.V.
1
In Commercial Distribution

  • 08720299502352 ()


  • X-ray image interpretive software
StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
NICo-Lab B.V.
3
In Commercial Distribution

  • 08720299502338 ()


  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
1.7.y
In Commercial Distribution

  • 08719326450131 ()


  • X-ray image interpretive software
The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDM systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications, region based scores, displayed upon the physicians query, indicating the likelihood that cancer is present in specific regions, and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara.
Screenpoint Medical B.V.
1.5.0 2D
In Commercial Distribution

  • 08719326450124 ()


  • X-ray image interpretive software
Transpara™ software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara™.
Screenpoint Medical B.V.
1.x.y
In Commercial Distribution

  • 08719326450117 ()


  • X-ray image interpretive software
The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications; region‐based scores, displayed upon the physician’s query, indicating the likelihood that cancer is present in specific regions; and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara.
Screenpoint Medical B.V.
1.3.y
In Commercial Distribution

  • 08719326450100 ()


  • X-ray image interpretive software
No Description
VUNO Inc.
VN-M-30
In Commercial Distribution

  • 08800045800342 ()


  • X-ray image interpretive software
Lunit INSIGHT CXR Triage - Windows version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000179 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000162 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000148 ()


  • X-ray image interpretive software
Linux version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000124 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000056 ()


  • X-ray image interpretive software
Designated Medical Device, Critical Care Suite PACS 1.0
GE MEDICAL SYSTEMS, INC.
PACS 1.0
In Commercial Distribution

  • 00840682147231 ()


  • X-ray image interpretive software
No Description
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00840682146340 ()


  • X-ray image interpretive software
No Description
MILVUE
V2.x.x
In Commercial Distribution

  • 03770024774016 ()


  • X-ray image interpretive software
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