The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for 1.10-year Fracture Risk Questionnaire Option For Qdr X-ray Bone Densitometer, Model Qdr Option.
| Device ID | K080711 |
| 510k Number | K080711 |
| Device Name: | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Bryan Cowell |
| Correspondent | Bryan Cowell HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-13 |
| Decision Date | 2008-09-02 |
| Summary: | summary |