510(k) K101036 ยท IZX Collimator, Manual, Radiographic
SHIMADZU COLLIMATOR R-20J
| Applicant | Shimadzu Corp., Torrance CA, US |
| Decision | Substantially Equivalent, Aug 26, 2010 |
| Received | Apr 14, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K101036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Shimadzu Medical Systems R-20J , Diagnostic X-Ray Beam-Limiting Device.
In combination with any of below X-Ray tubes:
06/1.2P364DK-85, 0.6/1.2P324DK-125,
06/1.2P324DK-85, 0.6/1.2P38DE-85.
Product Usage:
The device is the b Terminated |
IZX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.