510(k) K041380 ยท OEB Lung Computed Tomography System, Computer-Aided Detection
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
| Applicant | R2 Technology, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 8, 2004 |
| Received | May 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041380
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.