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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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qER-Quant - 00860005118137

The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution

  • 00860005118137 ()


  • Radiology DICOM image processing application software

Neosoma Glioma - 00860009223653

No Description
Neosoma, Inc.
2
In Commercial Distribution



  • Image segmentation application software

Neosoma Dashboard - 00860009223646

No Description
Neosoma, Inc.
3
In Commercial Distribution

  • 00860009223646 ()


  • Image segmentation application software

Neosoma HGG - 00860009223639

No Description
Neosoma, Inc.
2
In Commercial Distribution

  • 00860009223639 ()


  • Image segmentation application software

Neosoma Dashboard - 00860009223622

No Description
Neosoma, Inc.
2
Not in Commercial Distribution

  • 00860009223622 ()


  • Image segmentation application software

Neosoma Dashboard - 00860009223615

No Description
Neosoma, Inc.
2.3.2.0
Not in Commercial Distribution

  • 00860009223615 ()


  • Image segmentation application software

Neosoma HGG - 00860009223608

No Description
Neosoma, Inc.
2.1.2.0
Not in Commercial Distribution

  • 00860009223608 ()


  • Image segmentation application software

Ezra Flash - 00860010264621

No Description
Ezra Ai, Inc.
FLHAI01PL02IF01IT01LB02
In Commercial Distribution

  • 00860010264621 ()


  • Radiology DICOM image processing application software

SKOUT system - 00860010168417

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

SKOUT system - 00860010168400

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
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