K992677 is an FDA 510(k) clearance for the EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W. 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 September 3, 1999, 24 days after receiving the submission on August 10, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K992677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1999 |
| Decision Date | September 03, 1999 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KGI — Densitometer, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1170 |