MR DWI/FLAIR Measurement V1.0 is an AI-enabled medical device from Olea Medical that the U.S. FDA cleared through 510(k) K230552 on April 26, 2023. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).
See also FDA-cleared AI radiology devices in 2023, all FDA AI clearances in 2023, top radiology AI devices.
Key facts
| Submission number | K230552 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Olea Medical |
| Lead review panel | Radiology |
| Primary product code | LLZ — System, Image Processing, Radiological |
| Applicant (openFDA) | Olea Medical |
| Applicant location | La Ciotat, FR |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.2050 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. MR DWI/FLAIR Measurement V1.0 went through this pathway (K230552).
openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.
Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #125 of 161 under that code. Olea Medical has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
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