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Olea Medical

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

Total Devices6
Categories2
Latest Approval2023-06-09
TypeNumberDevice NameCodeDate
510(k) K223091 CT Perfusion V1.0 LLZ 2023-06-09 View
510(k) K223532 Olea S.I.A. Neurovascular V1.0 LLZ 2023-06-06 View
510(k) K230552 MR DWI/FLAIR Measurement V1.0 LLZ 2023-04-26 View
510(k) K223502 MR Diffusion Perfusion Mismatch V1.0 LLZ 2023-01-13 View
510(k) K211431 breastscape v1.0 QIH 2021-08-02 View
510(k) K152602 Olea Sphere V3.0 LLZ 2016-03-03 View