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Brainomix 360 e-MRI 12.1

by Brainomix Limited

Brainomix 360 e-MRI 12.1 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K231656 on 30 Aug 2023 and listed in FDA GUDID since 30 Mar 2026 (UDI-DI B720BX360EMRI1210), 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) K231656

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 NumberB720BX360EMRI1210 UDI-DI Date30 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK231656 Date30 Aug 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231656 decided 30 Aug 2023 Active
  • FDA GUDID UDI-DI B720BX360EMRI1210 listed 30 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231656
  2. Listed FDA GUDID B720BX360EMRI1210

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Brainomix 360 e-MRI
Generic name
X-ray image interpretive software
Model / reference
12.1
Primary DI / UDI-DI
B720BX360EMRI1210
510(k) Number
FDA product code
LLZ
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K231656)

and 2 more cleared under K231656

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Brainomix Limited

See all devices from Brainomix Limited →

Properties

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