510(k) K943545 ยท IZI System, X-Ray, Angiographic
CEILING SUSPENDED C-ARM SUPPORT MH-100
| Applicant | Shimadzu Medical Systems, Torrance CA, US |
| Decision | Substantially Equivalent, Feb 3, 1995 |
| Received | Jul 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Shimadzu Medical Systems MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational Open, Classified |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.