510(k) K021314 ยท LLZ System, Image Processing, Radiological
SCEPTRE-VS
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Jul 2, 2002 |
| Received | Apr 25, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021314
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.