Data / Medical devices / Portugal / AI4MedImaging Medical Solutions S.A.
AI4MedImaging Medical Solutions S.A.: FDA-registered device maker in Braga, Portugal, 2 510(k) clearances
AI4MedImaging Medical Solutions S.A. is registered with the FDA (registration 3025308066) in Braga, Portugal. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 11, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3025308066
- Address
- Rua do Parque Poente, Lt 35, Braga, Portugal, 4705-002
- Owner or operator
- AI4MedImaging Medical Solutions S.A. (10086592)
- Roles
- Manufacturer
- First device listed
- November 22, 2022
- Registered through
- 2027
- Brand names listed
- AI4CMR v1, AI4CMR v2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 11, 2026 | K252084 | AI4CMR v2.0 | QIH | Substantially Equivalent | Ai4medimaging Medical Solutions S.A. | accessdata.fda.gov |
| July 22, 2022 | K220624 | AI4CMR v1.0 | LLZ | Substantially Equivalent | Ai4medimaging Medical Solutions S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated February 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.