# Olea Medical

- Location (FDA's records): La Ciotat, FR
- FDA decisions: 14 (2009–2025): 14 510(k) clearances
- Names in FDA's records: Olea Medical (11); Olea Medical S.A.S. (3)
- Product codes: LLZ (12), LNH (1), QIH (1)
- 510(k) review time since 2016: median 174 days, against 157 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 18 (9 its own); citations of its devices by later devices: 20 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Nordicimaginglab AS: 2 (https://510kreport.com/company/nordicimaginglab)
- Nordicicemedical AS: 1 (https://510kreport.com/company/nordicicemedical)
- Imaging Biometrics, LLC: 1 (https://510kreport.com/company/imaging-biometrics)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Nordicneurolab AS: 1 (https://510kreport.com/company/nordicneurolab)

## Firms that cite its devices most
- Carestream Health, Inc.: 3 (https://510kreport.com/company/carestream-health)
- Philips Medical Systems Nederland B.V.: 2 (https://510kreport.com/company/philips-medical-systems-nederland)
- Perspectum, Ltd.: 1 (https://510kreport.com/company/perspectum)
- Ischemaview, Inc.: 1 (https://510kreport.com/company/ischemaview)
- Nordicneurolab AS: 1 (https://510kreport.com/company/nordicneurolab)
- Translational Mri, LLC: 1 (https://510kreport.com/company/translational-mri)
- Quibim S.L.: 1 (https://510kreport.com/company/quibim)
- Image Analysis, Inc.: 1 (https://510kreport.com/company/image-analysis)

## Its most-cited devices
- K152602: Olea Sphere V3.0 (2016), cited by 11
- K120196: Olea Sphere (2012), cited by 3
- K132095: Olea Sphere (2013), cited by 3
- K111161: Perfscape V2.0 (2011), cited by 2
- K223532: Olea S.I.A. Neurovascular V1.0 (2023), cited by 1

## Recent decisions
- K243680: Neurovascular Insight V1.0 (Aug 25, 2025)
- K243681: Neuro Insight V1.0 (Jul 23, 2025)
- K223091: CT Perfusion V1.0 (Jun 9, 2023)
- K223532: Olea S.I.A. Neurovascular V1.0 (Jun 6, 2023)
- K230552: MR DWI/FLAIR Measurement V1.0 (Apr 26, 2023)
- K223502: MR Diffusion Perfusion Mismatch V1.0 (Jan 13, 2023)
- K221426: Functional MR V1.0 (Jul 6, 2022)
- K211431: breastscape v1.0 (Aug 2, 2021)

Source page: https://510kreport.com/company/olea-medical