K230552 is an FDA 510(k) clearance for the MR DWI/FLAIR Measurement V1.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Olea Medical (La Ciotat, FR). The FDA issued a Cleared decision on April 26, 2023, 57 days after receiving the submission on February 28, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K230552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2023 |
| Decision Date | April 26, 2023 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |