VinDr-Mammo is an AI-enabled medical device from VinBigData Joint Stock Company that the U.S. FDA cleared through 510(k) K233108 on May 23, 2024. Its lead review panel is Radiology and its primary product code is QFM (Radiological Computer-Assisted Prioritization Software For Lesions).
See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.
Key facts
| Submission number | K233108 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | VinBigData Joint Stock Company |
| Lead review panel | Radiology |
| Primary product code | QFM — Radiological Computer-Assisted Prioritization Software For Lesions |
| Applicant (openFDA) | Vinbigdata Joint Stock Company |
| Applicant location | Ha Noi, VN |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.2080 |
| 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. VinDr-Mammo went through this pathway (K233108).
openFDA lists it as a Class 2 device under 21 CFR 892.2080. Class II devices are moderate risk and are subject to general and special controls.
Product code QFM covers 40 devices on the FDA AI list. By decision date, this device is #33 of 40 under that code. VinBigData Joint Stock Company has 1 AI-enabled device 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.