510(k) K013723 ยท ITX Transducer, Ultrasonic, Diagnostic
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
| Applicant | Hitachi Medical Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 6, 2002 |
| Received | Nov 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2009 | Hitachi Medical Systems America Inc EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Terminated |
ITX | None listed |
| Jul 20, 2004 | Hitachi Medical Systems America Inc Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W. Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.