K061561 is an FDA 510(k) clearance for the HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on July 28, 2006, 53 days after receiving the submission on June 5, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K061561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2006 |
| Decision Date | July 28, 2006 |
| Days to Decision | 53 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 |