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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
Neosoma, Inc.
3
In Commercial Distribution

  • 00860009223646 ()


  • Image segmentation application software
No Description
Neosoma, Inc.
2
In Commercial Distribution

  • 00860009223639 ()


  • Image segmentation application software
No Description
Neosoma, Inc.
2
Not in Commercial Distribution

  • 00860009223622 ()


  • Image segmentation application software
No Description
Neosoma, Inc.
2.3.2.0
Not in Commercial Distribution

  • 00860009223615 ()


  • Image segmentation application software
No Description
Neosoma, Inc.
2.1.2.0
Not in Commercial Distribution

  • 00860009223608 ()


  • Image segmentation application software
No Description
Ezra Ai, Inc.
FLHAI01PL02IF01IT01LB02
In Commercial Distribution

  • 00860010264621 ()


  • Radiology DICOM image processing application software
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time
Iterative Scopes, Inc.
SKOUT210
In Commercial Distribution

  • 00860010168417 ()


  • Endoscopic video image interpretive unit
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Iterative Scopes, Inc.
SKOUT200
In Commercial Distribution

  • 00860010168400 ()


  • Endoscopic video image interpretive unit
Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages.
Videahealth, Inc.
VPA01BP
In Commercial Distribution

  • 00860009836815 ()


  • Dental x-ray image interpretive software
Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation.
MEDICAL METRICS, INC
SpineCAMP
In Commercial Distribution

  • 00860011655701 ()


  • Radiology DICOM image processing application software
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