510(k) K862164 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER
| Applicant | Hitachi Medical Corp. of America, Tarrytown NY, US |
| Decision | Substantially Equivalent for Some Indications, Nov 4, 1986 |
| Received | Jun 6, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862164
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.