K103265 is an FDA 510(k) clearance for the NHANES WHOLE BODY DXA REFERENCE DATABASE. 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 March 16, 2011, 132 days after receiving the submission on November 4, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K103265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2010 |
| Decision Date | March 16, 2011 |
| Days to Decision | 132 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 |