The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr-2000 X-ray Bone Densitometer.
| Device ID | K913321 |
| 510k Number | K913321 |
| Device Name: | HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Von Stetten |
| Correspondent | 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 | 1991-07-25 |
| Decision Date | 1991-11-01 |