Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Olea Medical

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2023-06-09
TypeNumberDevice NameCodeDateActions
510(k) K223091 CT Perfusion V1.0LLZ2023-06-09 View
510(k) K223532 Olea S.I.A. Neurovascular V1.0LLZ2023-06-06 View
510(k) K230552 MR DWI/FLAIR Measurement V1.0LLZ2023-04-26 View
510(k) K223502 MR Diffusion Perfusion Mismatch V1.0LLZ2023-01-13 View
510(k) K211431 breastscape v1.0QIH2021-08-02 View
510(k) K152602 Olea Sphere V3.0LLZ2016-03-03 View
↑