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e-ASPECTS 11.1

by Brainomix Limited

e-ASPECTS 11.1 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K221564 on 23 Feb 2023 and listed in FDA GUDID since 6 Apr 2023 (UDI-DI B720BX360EASPECTS1110), 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) K221564

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 NumberB720BX360EASPECTS1110 UDI-DI Date6 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK221564 Date23 Feb 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221564 decided 23 Feb 2023 Active
  • FDA GUDID UDI-DI B720BX360EASPECTS1110 listed 6 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221564
  2. Listed FDA GUDID B720BX360EASPECTS1110

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
e-ASPECTS
Generic name
X-ray image interpretive software
Model / reference
11.1
Primary DI / UDI-DI
B720BX360EASPECTS1110
510(k) Number
FDA product code
POK
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2060
GUDID distribution status
In Commercial Distribution

Related devices

Category: X-ray image interpretive software

Similar devices

Other devices filed under FDA product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Other devices from Brainomix Limited

See all devices from Brainomix Limited →

Properties

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