510(k) K043617 ยท OEB Lung Computed Tomography System, Computer-Aided Detection
IMAGECHECKER CT CAD SOFTWARE SYSTEM
| Applicant | Hologic, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 21, 2007 |
| Received | Nov 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043617
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.