510(k) K121545 ยท LNH System, Nuclear Magnetic Resonance Imaging
BELLYBOARD, SBRT ACCESSORIES
| Applicant | Medtec Inc. Dba Civco Medical Solutions, Orange City IA, US |
| Decision | Substantially Equivalent, Jun 8, 2012 |
| Received | May 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2014 | Civco Medical Instruments Inc Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box.
Product Usage: This device is intended to reduce the irradiated small bowel volume of Terminated |
IYE | None listed |
| Jan 21, 2014 | Civco Medical Instruments Inc Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box.
Product Usage: This device is intended to reduce the irradiated small bowel volume Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.