510(k) K052500 ยท IZI System, X-Ray, Angiographic
DAR-8000F
| Applicant | Shimadzu Medical Systems, Torrance CA, US |
| Decision | Substantially Equivalent, Oct 17, 2005 |
| Received | Sep 13, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052500
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2018 | Shimadzu Medical Systems Sonialvision Safire II, Model #: DAR-8000f
Product Usage:
This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated an Terminated |
IZI | None listed |
| May 8, 2014 | Shimadzu Medical Systems Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f.
This device is intended to be used for radiography in the hospital with X-ray devices. Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.