K961787 is an FDA 510(k) clearance for the BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Hologic, Inc. (Rockville, US). The FDA issued a Cleared decision on June 13, 1997, 400 days after receiving the submission on May 9, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K961787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1996 |
| Decision Date | June 13, 1997 |
| Days to Decision | 400 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KGI — Densitometer, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1170 |