510(k) K013722 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
| Applicant | Hitachi Medical Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 11, 2002 |
| Received | Nov 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013722
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2009 | Hitachi Medical Systems America Inc EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners,
DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A. Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.