OLEA MEDICAL
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0122-2024 | Class II | Functional MR V1.0 | August 10, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243680 | Neurovascular Insight V1.0 | August 25, 2025 |
| K243681 | Neuro Insight V1.0 | July 23, 2025 |
| K223091 | CT Perfusion V1.0 | June 9, 2023 |
| K223532 | Olea S.I.A. Neurovascular V1.0 | June 6, 2023 |
| K230552 | MR DWI/FLAIR Measurement V1.0 | April 26, 2023 |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | January 13, 2023 |
| K221426 | Functional MR V1.0 | July 6, 2022 |
| K211431 | breastscape v1.0 | August 2, 2021 |
| K152602 | Olea Sphere V3.0 | March 3, 2016 |
| K132095 | OLEA SPHERE | December 26, 2013 |
| K120196 | OLEA SPHERE | April 19, 2012 |
| K111161 | PERFSCAPE V2.0 | November 4, 2011 |
| K091444 | PERFSCAPE | July 20, 2009 |
| K083491 | NEUROSCAPE | February 19, 2009 |