510(k) K052943 ยท KPR System, X-Ray, Stationary
DDRFORMULA AND DDRFORMULA PLUS
| Applicant | Swissray Medical AG, Elizabeth NJ, US |
| Decision | Substantially Equivalent, Dec 15, 2005 |
| Received | Oct 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052943
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2018 | Swissray Medical ddR Formula B X-ray System, ddR Formula B
Product Usage:
X-ray system used for imaging Open, Classified |
KPR | None listed |
| Sep 18, 2018 | Swissray Medical ddR Formula B X-ray System, Model ddR Formula B
X-ray system used for imaging Open, Classified |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.