K091325 is an FDA 510(k) clearance for the TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Cooper Surgical (Trumbull, US). The FDA issued a Cleared decision on June 29, 2009, 55 days after receiving the submission on May 5, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K091325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2009 |
| Decision Date | June 29, 2009 |
| Days to Decision | 55 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 |