ABMD Software is an AI-enabled medical device from HeartLung Corporation that the U.S. FDA cleared through 510(k) K213760 on July 29, 2022. Its lead review panel is Radiology and its primary product code is KGI (Densitometer, Bone).
See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.
Key facts
| Submission number | K213760 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | HeartLung Corporation |
| Lead review panel | Radiology |
| Primary product code | KGI — Densitometer, Bone |
| Applicant (openFDA) | HeartLung Corporation |
| Applicant location | Torrance, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1170 |
| 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. ABMD Software went through this pathway (K213760).
openFDA lists it as a Class 2 device under 21 CFR 892.1170. Class II devices are moderate risk and are subject to general and special controls.
Product code KGI covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. HeartLung Corporation 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.