510(k) K041763 ยท IZL System, X-Ray, Mobile
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
| Applicant | Shimadzu Corp., Torrance CA, US |
| Decision | Substantially Equivalent, Jul 13, 2004 |
| Received | Jun 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Shimadzu Medical Systems 0.7/1.3U163CS-36
In combination with below systems
MobileArt Evolution, MobileDaRt Evolution
Product Usage:
The device is a mobile X-ray system in order to take general radiography of patients in the Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.