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Olea Medical

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
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
510(k) K132095 OLEA SPHERELLZ2013-12-26 View
510(k) K120196 OLEA SPHERELLZ2012-04-19 View
510(k) K111161 PERFSCAPE V2.0LLZ2011-11-04 View
510(k) K091444 PERFSCAPELNH2009-07-20 View
510(k) K083491 NEUROSCAPELLZ2009-02-19 View
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