EdgeFlow UH10 is an AI-enabled medical device from Edgecare Inc. that the U.S. FDA cleared through 510(k) K231677 on March 6, 2024. Its lead review panel is Radiology and its primary product code is IYO (System, Imaging, Pulsed Echo, Ultrasonic).
See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.
Key facts
| Submission number | K231677 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Edgecare Inc. |
| Lead review panel | Radiology |
| Primary product code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant (openFDA) | Edgecare, Inc. |
| Applicant location | Seoul, KR |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1560 |
| 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. EdgeFlow UH10 went through this pathway (K231677).
openFDA lists it as a Class 2 device under 21 CFR 892.1560. Class II devices are moderate risk and are subject to general and special controls.
Product code IYO covers 12 devices on the FDA AI list. By decision date, this device is #6 of 12 under that code. Edgecare Inc. 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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