Skip to content

Cognet AI MT+

by Medcognetics, Inc

Cognet AI MT+ is a X-ray image interpretive software (FDA Class II; FDA product code QFM, Radiological Computer-Assisted Prioritization Software For Lesions) made by Medcognetics, Inc, cleared under FDA 510(k) K252482 on 11 Dec 2025 and listed in FDA GUDID since 21 May 2026 (UDI-DI 00860007434716), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K252482

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860007434716 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252482 Date11 Dec 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252482 decided 11 Dec 2025 Active
  • FDA GUDID UDI-DI 00860007434716 listed 21 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252482
  2. Listed FDA GUDID 00860007434716

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cognet AI
Generic name
X-ray image interpretive software
Model / reference
MT+
Primary DI / UDI-DI
00860007434716
510(k) Number
FDA product code
QFM
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2080
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions).

Other devices from Medcognetics, Inc

  • Cognet AI MT

    Class II

  • CogNet QmTRIAGE

    Class II

  • CogNet AI-MT+

    Class II

Properties

  • Prescription use
Other properties (14, all answered No)