510(k) K113276 ยท IYE Accelerator, Linear, Medical
CATALYST
| Applicant | C-Rad Positioning AB, Uppsala, SE |
| Decision | Substantially Equivalent, Feb 27, 2012 |
| Received | Nov 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2020 | C-RAD POSITIONING AB PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.