The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr Series X-ray Boe Densitometers.
| Device ID | K963363 |
| 510k Number | K963363 |
| Device Name: | HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Eric Von Stetten, Ph.d. |
| Correspondent | Eric Von Stetten, Ph.d. 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 | 1996-08-27 |
| Decision Date | 1996-11-22 |
| Summary: | summary |