510(k) K080711 ยท KGI Densitometer, Bone
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
| Applicant | Hologic, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Sep 2, 2008 |
| Received | Mar 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080711
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2008 | Hologic, Inc. Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software Terminated |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.