510(k) K173713 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HS70A Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Mar 8, 2018 |
| Received | Dec 4, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2019 | NeuroLogica Corporation HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.