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Triage Stroke 14.1

by Brainomix Limited

Triage Stroke 14.1 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K251983 on 26 Aug 2025 and listed in FDA GUDID since 28 Nov 2025 (UDI-DI B720BX360TRIAGESTRO141), active as of 23 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 23 Oct 2026

Documents

510(k) K251983

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB720BX360TRIAGESTRO141 UDI-DI Date28 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251983 Date26 Aug 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251983 decided 26 Aug 2025 Active
  • FDA GUDID UDI-DI B720BX360TRIAGESTRO141 listed 28 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251983
  2. Listed FDA GUDID B720BX360TRIAGESTRO141

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Triage Stroke
Generic name
X-ray image interpretive software
Model / reference
14.1
Primary DI / UDI-DI
B720BX360TRIAGESTRO141
510(k) Number
FDA product code
QAS
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2080
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251983)

Similar devices

Other devices filed under FDA product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Other devices from Brainomix Limited

See all devices from Brainomix Limited →

Properties

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