The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Option For The Qdr Bone Densitometer, Models Qdr4500, Qdr2000, Qdr1500, Qdr4000, Qdr1000, Qdr1000w.
| Device ID | K992775 |
| 510k Number | K992775 |
| Device Name: | OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Nandini Murthy |
| Correspondent | Nandini Murthy 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 | 1999-08-18 |
| Decision Date | 1999-10-01 |
| Summary: | summary |