K072664 is an FDA 510(k) clearance for the GE LUNAR FEMUR STRENGTH SOFTWARE. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Ge Medical Systems Ultrasound and Primary Care Dia (Madison, US). The FDA issued a Cleared decision on November 21, 2008, 428 days after receiving the submission on September 20, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K072664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2007 |
| Decision Date | November 21, 2008 |
| Days to Decision | 428 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 |