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AI4CMR v2.0

by AI4MEDIMAGING - Medical Solutions, S.A.

AI4CMR v2.0 is a Class II device made by AI4MEDIMAGING - Medical Solutions, S.A., listed in FDA GUDID since 5 Aug 2026 (UDI-DI 05600250059046), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05600250059046 UDI-DI Date5 Aug 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
AI4CMR
Generic name
MRI system application software
Model / reference
v2.0
Primary DI / UDI-DI
05600250059046
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

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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

  • AI4CMR v1.0

    Class II

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)