V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison Co., Ltd., listed by FDA (510(k), K223387) with a decision date of 2023-02-13. Review panel: Radiology.
| FDA submission number | K223387 |
|---|---|
| Pathway | 510(k) |
| Company | Samsung Medison Co., Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-02-13 |
| Decision | Substantially Equivalent |
| Product code | IYN |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | 2 |
| Regulation number | 892.1550 |
| Review time (calendar days) | 98 |
| Applicant country | KR |
Official FDA database record · FDA AI-enabled device list
More devices from Samsung Medison Co., Ltd. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.