K023398 is an FDA 510(k) clearance for the HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY. 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 November 8, 2002, 30 days after receiving the submission on October 9, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K023398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2002 |
| Decision Date | November 08, 2002 |
| Days to Decision | 30 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 |