Device
The CogNet AI-MT+ is a software as a Medical Device for screening Mammograms in DBT format. This software is a triage device that allows the result to be prioritized for viewing by...
Manufacturer
Medcognetics Inc
Model: MT+ DI: 00860007434716 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-21 Current Version: 2026-05-29
Description
The CogNet AI-MT+ is a software as a Medical Device for screening Mammograms in DBT format. This software is a triage device that allows the result to be prioritized for viewing by a qualified radiologist.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 92933112-7ba8-410c-bf37-ccfddb385025
Distribution Status: In Commercial Distribution
DUNS Number: 118829744
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00860007434716
Type: Primary
Issuing Agency: GS1
GMDN
Code: 63386
Name: X-ray image interpretive software
Definition:
An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].
FDA Product Codes
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
Premarket Submissions
Submission Number: K252482
Supplement Number: 000