Rayvolve is an AI-enabled medical device from AZmed SAS that the U.S. FDA cleared through 510(k) K240845 on July 17, 2024. Its lead review panel is Radiology and its primary product code is QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).
See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.
Key facts
| Submission number | K240845 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | AZmed SAS |
| Lead review panel | Radiology |
| Primary product code | QBS — Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| Applicant (openFDA) | Azmed Sas |
| Applicant location | Laval, FR |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.2090 |
| 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. Rayvolve went through this pathway (K240845).
openFDA lists it as a Class 2 device under 21 CFR 892.2090. Class II devices are moderate risk and are subject to general and special controls.
Product code QBS covers 10 devices on the FDA AI list. By decision date, this device is #7 of 10 under that code. AZmed SAS has 2 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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