510(k) K153529 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
WS80A Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Feb 2, 2016 |
| Received | Dec 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2019 | NeuroLogica Corporation WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07,
3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.