510(k) K063518 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Dec 21, 2006 |
| Received | Nov 21, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063518
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.