V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison Co., Ltd. that the U.S. FDA cleared through 510(k) K242511 on December 10, 2024. Its lead review panel is Radiology and its primary product code is IYN (System, Imaging, Pulsed Doppler, Ultrasonic).
See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.
Key facts
| Submission number | K242511 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Samsung Medison Co., Ltd. |
| Lead review panel | Radiology |
| Primary product code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant (openFDA) | Samsung Medison Co., Ltd. |
| Applicant location | Hongcheon-Gun, KR |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1550 |
| 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. V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System went through this pathway (K242511).
openFDA lists it as a Class 2 device under 21 CFR 892.1550. Class II devices are moderate risk and are subject to general and special controls.
Product code IYN covers 124 devices on the FDA AI list. By decision date, this device is #78 of 124 under that code. Samsung Medison Co., Ltd. has 18 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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