510(k) K012546 ยท KPR System, X-Ray, Stationary
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
| Applicant | Sedecal USA, Inc., Deer Field IL, US |
| Decision | Substantially Equivalent, Nov 2, 2001 |
| Received | Aug 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2024 | SEDECAL SA Sedecal X Optima URS digital mobile diagnostic x-ray system.
A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying posi Open, Classified |
KPR | None listed |
| Apr 25, 2003 | Sedecal USA, Inc. Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.