The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Body Composition Software Option For Qdr X-ray Bone Densitometers.
| Device ID | K961787 |
| 510k Number | K961787 |
| Device Name: | BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Contact | R. Michael Crompton |
| Correspondent | R. Michael Crompton HOLOGIC, INC. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1997-06-13 |
| Summary: | summary |