510(k) K083423 ยท NWE Colon Computed Tomography System, Computer Aided Detection
COLONCAD API 3.1
| Applicant | Medicsight Plc, London, GB |
| Decision | Substantially Equivalent, May 17, 2011 |
| Received | Nov 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083423
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.