Radiography 7300 C is an AI-enabled medical device from Philips Medical Systems DMC GmbH that the U.S. FDA cleared through 510(k) K233662 on June 13, 2024. Its lead review panel is Radiology and its primary product code is KPR (System, X-Ray, Stationary).
See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.
Key facts
| Submission number | K233662 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Philips Medical Systems DMC GmbH |
| Lead review panel | Radiology |
| Primary product code | KPR — System, X-Ray, Stationary |
| Applicant (openFDA) | Philips Medical Systems Dmc GmbH |
| Applicant location | Hamburg, DE |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1680 |
| 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. Radiography 7300 C went through this pathway (K233662).
openFDA lists it as a Class 2 device under 21 CFR 892.1680. Class II devices are moderate risk and are subject to general and special controls.
Product code KPR covers 6 devices on the FDA AI list. By decision date, this device is #3 of 6 under that code. Philips Medical Systems DMC GmbH 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.