QT Scanner 2000 Model A is an AI-enabled medical device from QT Imaging Holdings, Inc. that the U.S. FDA cleared through 510(k) K253898 on March 4, 2026. 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 2026, all FDA AI clearances in 2026, top radiology AI devices.
Key facts
| Submission number | K253898 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | QT Imaging Holdings, Inc. |
| Lead review panel | Radiology |
| Primary product code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant (openFDA) | QT Imaging Holdings, Inc. |
| Applicant location | Novato, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1560 |
| Decision code | SESE |
| Submission type | Special |
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. QT Scanner 2000 Model A went through this pathway (K253898).
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 #10 of 12 under that code. QT Imaging Holdings, Inc. 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.