510(k) K933227 ยท IYE Accelerator, Linear, Medical
UNI-FRAME HEAD IMMOBILIZATION SYSTEM
| Applicant | Medtec, Inc., Orange City IA, US |
| Decision | Substantially Equivalent, Jul 18, 1994 |
| Received | Jul 2, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2020 | Med Tec Inc Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning. Terminated |
IYE | None listed |
| Nov 6, 2009 | Med Tec Inc CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.