La Ciotat, FR · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 4 | 2023-06-09 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 1 | 2021-08-02 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-08-10 | Class II | Ongoing | Z-0122-2024 | Functional MR V1.0 | — | When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance sof… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-06-09 | K223091 | CT Perfusion V1.0 | LLZ | Class II | Radiology |
| 2023-06-06 | K223532 | Olea S.I.A. Neurovascular V1.0 | LLZ | Class II | Radiology |
| 2023-04-26 | K230552 | MR DWI/FLAIR Measurement V1.0 | LLZ | Class II | Radiology |
| 2023-01-13 | K223502 | MR Diffusion Perfusion Mismatch V1.0 | LLZ | Class II | Radiology |
| 2021-08-02 | K211431 | breastscape v1.0 | QIH | Class II | Radiology |