510(k) K071614 ยท IYE Accelerator, Linear, Medical
FIDUCIAL MARKERS
| Applicant | Civco, Orange City IA, US |
| Decision | Substantially Equivalent, Sep 11, 2007 |
| Received | Jun 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2008 | Med Tec Inc dba CIVCO Medical Solutions Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041. Terminated |
IYE | None listed |
| May 21, 2008 | Med Tec Inc dba CIVCO Medical Solutions Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.