The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr-3000 X-ray Bone Densitometer.
| Device ID | K943505 |
| 510k Number | K943505 |
| Device Name: | HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Eric Von Stetten |
| Correspondent | Eric Von Stetten HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-20 |
| Decision Date | 1995-01-20 |