K071570 is an FDA 510(k) clearance for the GE LUNAR BODY COMPOSITION SOFTWARE. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Ge Medical Systems Lunar (Madison, US). The FDA issued a Cleared decision on June 27, 2007, 19 days after receiving the submission on June 8, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K071570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2007 |
| Decision Date | June 27, 2007 |
| Days to Decision | 19 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 |