K133664 is an FDA 510(k) clearance for the ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Ge Medical Systems Ultrasound & Primary Care Diagn (Madison, US). The FDA issued a Cleared decision on May 15, 2014, 167 days after receiving the submission on November 29, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K133664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2013 |
| Decision Date | May 15, 2014 |
| Days to Decision | 167 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 |