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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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No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586356 ()


  • Dental x-ray image interpretive software
The PHA Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The PHA Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
4.0.0
In Commercial Distribution

  • 00850894007902 ()


  • X-ray image interpretive software
ClearPoint Maestro Brain Model Software Version 1.0
Clearpoint Neuro, Inc.
CPM-SFW-1
In Commercial Distribution

  • 00850359007966 ()
CPM-SFW-1

  • Image segmentation application software
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution

  • 00850057636000 ()


  • Radiology DICOM image processing application software
FEops HEARTguide ALPACA
FEops
3.1.0
In Commercial Distribution

  • 05430002070087 ()
05430002070087

  • Radiology DICOM image processing application software
FEops HEARTguide ALPACA 3.0.1 / 3.0.2
FEops
3.0.1
Not in Commercial Distribution

  • 05430002070063 ()


  • Radiology DICOM image processing application software
No Description
Disior Oy
1.0
In Commercial Distribution

  • 06429810209047 ()


  • CAD/CAM software
No Description
Disior Oy
1.0
In Commercial Distribution

  • 06429810209030 ()


  • CAD/CAM software
Burn Navigator RX
ARCOS, INC.
RX
In Commercial Distribution

  • B2551143 ()
1143

  • Clinical information system web-based application software
Burn Navigator H2 Transport
ARCOS, INC.
H2 Transport
In Commercial Distribution

  • B2551125 ()
1125

  • Clinical information system web-based application software
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