510(k) K263150 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Dia
| Applicant | Samsung Medison Co., Ltd., Hongcheon-Gun, KR |
| Decision | Substantially Equivalent, Oct 8, 2026 |
| Received | Sep 8, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K263150
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.