HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison CO., LTD., listed by FDA (510(k), K230084) with a decision date of 2023-04-21. Review panel: Radiology.
| FDA submission number | K230084 |
|---|---|
| Pathway | 510(k) |
| Company | Samsung Medison CO., LTD. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-04-21 |
| Decision | Substantially Equivalent |
| Product code | IYN |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | 2 |
| Regulation number | 892.1550 |
| Review time (calendar days) | 100 |
| Applicant country | KR |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.