The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Fracture Risk Option For The Qdr Bone Densitometer, Model#s Qdr4500, Qdr2000, Qdr1500, Qdr4000, Qdr1000, Qdr1000w.
| Device ID | K983028 |
| 510k Number | K983028 |
| Device Name: | FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Nandini Murphy |
| Correspondent | Nandini Murphy 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 | 1998-08-31 |
| Decision Date | 1998-11-13 |
| Summary: | summary |