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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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