510(k) K252018 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Hongcheon-Gun, KR |
| Decision | Substantially Equivalent, Jan 5, 2026 |
| Received | Jun 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252018
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.