FDA applicant
Peek Health, S.A.
FDA records 7 decisions for Peek Health, S.A. (Braga, PT) from 2018 to 2025: 7 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Peek Health, S.A.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Peek Health, S.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report