Data / Medical devices / Portugal / Peek Health, S.A.
Peek Health, S.A.: FDA-registered device maker in Braga, Portugal, 1 510(k) clearance
Peek Health, S.A. is registered with the FDA (registration 3035455070) in Braga, Portugal. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035455070
- Address
- Centro de Negocios Ideia Atlantico Rua Padres Carmelitas, Braga, Portugal, 4719-005
- Owner or operator
- Peek Health, S.A. (10092581)
- Roles
- Manufacturer
- First device listed
- January 14, 2026
- Registered through
- 2026
- Brand names listed
- PeekMed web
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 |
|---|---|---|---|---|---|---|
| December 22, 2025 | K252856 | PeekMed web | QIH | Substantially Equivalent | Peek Health, 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 December 22, 2025. 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.