510(k) K090578 ยท IZW Collimator, Automatic, Radiographic
SHIMADZU COLLIMATOR R-30H
| Applicant | Shimadzu Corp., Torrance CA, US |
| Decision | Substantially Equivalent, Nov 6, 2009 |
| Received | Mar 3, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K090578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Shimadzu Medical Systems R-30H , Diagnostic X-Ray Beam-Limiting Device.
In combination with any of below X-ray tubes
0.6/1.2P364DK-85, 0.6/1.2P324DK-125,
0.6/1.2P324DK-85, 0.6/1.2P38DE-85
Device Model # R-30H.
Subsequent Terminated |
IZW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.