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AI4CMR v1.0

by AI4MEDIMAGING - Medical Solutions, S.A.

AI4CMR v1.0 is a Class II device made by AI4MEDIMAGING - Medical Solutions, S.A., cleared under FDA 510(k) K220624 on 22 Jul 2022 and listed in FDA GUDID since 4 Jan 2023 (UDI-DI 05600250059022), 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) K220624

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 Number05600250059022 UDI-DI Date4 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220624 Date22 Jul 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220624 decided 22 Jul 2022 Active
  • FDA GUDID UDI-DI 05600250059022 listed 4 Jan 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220624
  2. Listed FDA GUDID 05600250059022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AI4CMR
Generic name
MRI system application software
Model / reference
v1.0
Primary DI / UDI-DI
05600250059022
FDA product code
LLZ, QIH
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system application software

Similar devices in this category

Other devices filed under MRI system application software.

Other devices from AI4MEDIMAGING - Medical Solutions, S.A.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)