The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr X-ray Bone Densitometer/models Series 4500, 4000, 2000, 1000 And Hologic Delphi X-ray Bone Densitometer.
| Device ID | K002711 |
| 510k Number | K002711 |
| Device Name: | HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene 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 | 2000-08-31 |
| Decision Date | 2000-09-28 |