K963363 is an FDA 510(k) clearance for the HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on November 22, 1996, 87 days after receiving the submission on August 27, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K963363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1996 |
| Decision Date | November 22, 1996 |
| Days to Decision | 87 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 |