510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Olea Medical

La Ciotat Bouches-du-Rhone, FR

OLEA MEDICAL appears in FDA device records in La Ciotat Bouches-du-Rhone, FR. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Olea Medical between 2009 and 2023. The busiest year on record is 2023, with 4. The most recent is 2023, with 4.

Clearances by year, as a table
510(k) clearance decisions for Olea Medical, by decision year
YearClearances
20092
20111
20121
20131
20161
20211
20234
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223091CT Perfusion V1.0LLZSubstantially Equivalent
K223532Olea S.I.A. Neurovascular V1.0LLZSubstantially Equivalent
K230552MR DWI/FLAIR Measurement V1.0LLZSubstantially Equivalent
K223502MR Diffusion Perfusion Mismatch V1.0LLZSubstantially Equivalent
K211431breastscape v1.0QIHSubstantially Equivalent
K152602Olea Sphere V3.0LLZSubstantially Equivalent
K132095OLEA SPHERELLZSubstantially Equivalent
K120196OLEA SPHERELLZSubstantially Equivalent
K111161PERFSCAPE V2.0LLZSubstantially Equivalent
K091444PERFSCAPELNHSubstantially Equivalent
K083491NEUROSCAPELLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Olea Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30076759593007675959OLEA MEDICAL93 Avenue du Sorbier, Zone Athelia IV, La Ciotat Bouches-du-Rhone 13600 FR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0122-2024Functional MR V1.0When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain