510(k) K071806 ยท JAK System, X-Ray, Tomography, Computed
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Aug 28, 2007 |
| Received | Jul 2, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K071806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2009 | Hitachi Medical Systems America Inc Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.