The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Modified Qdr-1000 X-ray Bone Densitometer.
| Device ID | K890999 |
| 510k Number | K890999 |
| Device Name: | MODIFIED QDR-1000 X-RAY BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Thomas L Kelly |
| Correspondent | Thomas L Kelly 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 | 1989-02-27 |
| Decision Date | 1989-12-21 |