510(k) K090268 ยท IZL System, X-Ray, Mobile
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
| Applicant | Shimadzu Corp., Torrance CA, US |
| Decision | Substantially Equivalent, Jun 30, 2009 |
| Received | Feb 3, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K090268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Shimadzu Medical Systems 0.7/1.2JG326D-265
Product Usage:
The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.