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Brainomix 360 Hyperdensity 14.4

by Brainomix Limited

Brainomix 360 Hyperdensity 14.4 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K260406 on 12 Jun 2026 and listed in FDA GUDID since 18 Sep 2026 (UDI-DI B720BX360HYPERDENSI1440), 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) K260406

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 NumberB720BX360HYPERDENSI1440 UDI-DI Date18 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK260406 Date12 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K260406 decided 12 Jun 2026 Active
  • FDA GUDID UDI-DI B720BX360HYPERDENSI1440 listed 18 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K260406
  2. Listed FDA GUDID B720BX360HYPERDENSI1440

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  • Withdrawn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 Hyperdensity
Generic name
Brain CT/MRI clinical assessment support software
Model / reference
14.4
Primary DI / UDI-DI
B720BX360HYPERDENSI1440
510(k) Number
FDA product code
QIH
GMDN term
Brain CT/MRI clinical assessment support software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

Other devices from Brainomix Limited

See all devices from Brainomix Limited →

Properties

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