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e-ASPECTS 14.0

by Brainomix Limited

e-ASPECTS 14.0 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K243294 on 14 Feb 2025, registered in EUDAMED and listed in FDA GUDID since 18 Aug 2025 (UDI-DI B720BX360EASPECTS1400), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243294

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB720BX360EASPECTS1400 UDI-DI Date18 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK243294 Date14 Feb 2025IssuedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K243294 decided 14 Feb 2025 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI B720BX360EASPECTS1400 listed 18 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243294
  2. Listed FDA GUDID B720BX360EASPECTS1400

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
e-ASPECTS
Generic name
X-ray image interpretive software
Model / reference
14.0
Primary DI / UDI-DI
B720BX360EASPECTS1400
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

Cleared under the same submission (K243294)

and 3 more cleared under K243294

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)