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Brainomix 360 e-Lung 2.3

by Brainomix Limited

Brainomix 360 e-Lung 2.3 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K242411 on 19 Feb 2025 and listed in FDA GUDID since 30 Mar 2026 (UDI-DI B720BX360ELUNG230), 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) K242411

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 NumberB720BX360ELUNG230 UDI-DI Date30 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK242411 Date19 Feb 2025IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242411 decided 19 Feb 2025 Active
  • FDA GUDID UDI-DI B720BX360ELUNG230 listed 30 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242411
  2. Listed FDA GUDID B720BX360ELUNG230

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  • Withdrawn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-Lung
Generic name
X-ray image interpretive software
Model / reference
2.3
Primary DI / UDI-DI
B720BX360ELUNG230
510(k) Number
FDA product code
JAK
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242411)

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

Other devices from Brainomix Limited

See all devices from Brainomix Limited →

Properties

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