Red Dot is an AI-enabled medical device from Behold.AI Technologies Limited that the U.S. FDA cleared through 510(k) K191556 on February 28, 2020. 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 2020, all FDA AI clearances in 2020, top radiology AI devices.
Key facts
| Submission number | K191556 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Behold.AI Technologies Limited |
| Lead review panel | Radiology |
| Primary product code | QFM — Radiological Computer-Assisted Prioritization Software For Lesions |
| Applicant (openFDA) | Behold.Ai Technologies Limited |
| Applicant location | St. Leonards-On-Sea, GB |
| 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. Red Dot went through this pathway (K191556).
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 #5 of 40 under that code. Behold.AI Technologies Limited 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.