The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr Explorer X-ray Bone Densitometer, Model Explorer.
| Device ID | K033224 |
| 510k Number | K033224 |
| Device Name: | HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Daniel F Phelan |
| Correspondent | Daniel F Phelan HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-06 |
| Decision Date | 2003-11-05 |
| Summary: | summary |