FDA 510(k) Applications Submitted by OLEA MEDICAL

FDA 510(k) Number Submission Date Device Name Applicant
K132095 07/08/2013 OLEA SPHERE OLEA MEDICAL
K152602 09/11/2015 Olea Sphere V3.0 OLEA MEDICAL
K120196 01/23/2012 OLEA SPHERE OLEA MEDICAL
K111161 04/25/2011 PERFSCAPE V2.0 OLEA MEDICAL
K230552 02/28/2023 MR DWI/FLAIR Measurement V1.0 Olea Medical
K211431 05/07/2021 breastscape v1.0 Olea Medical
K223091 09/30/2022 CT Perfusion V1.0 Olea Medical
K223502 11/21/2022 MR Diffusion Perfusion Mismatch V1.0 Olea Medical
K223532 11/23/2022 Olea S.I.A. Neurovascular V1.0 Olea Medical
K091444 05/15/2009 PERFSCAPE OLEA MEDICAL
K083491 11/25/2008 NEUROSCAPE OLEA MEDICAL


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