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e-CTA 11.1

by Brainomix Limited

e-CTA 11.1 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K192692 on 28 May 2020 and listed in FDA GUDID since 6 Apr 2023 (UDI-DI B720BX360ECTA1110), 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) K192692

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 NumberB720BX360ECTA1110 UDI-DI Date6 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK192692 Date28 May 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192692 decided 28 May 2020 Active
  • FDA GUDID UDI-DI B720BX360ECTA1110 listed 6 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192692
  2. Listed FDA GUDID B720BX360ECTA1110

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
e-CTA
Generic name
X-ray image interpretive software
Model / reference
11.1
Primary DI / UDI-DI
B720BX360ECTA1110
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

Category: X-ray image interpretive software

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)