K052581 is an FDA 510(k) clearance for the LUNAR IDXA. 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 October 20, 2005, 30 days after receiving the submission on September 20, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K052581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2005 |
| Decision Date | October 20, 2005 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KGI - Densitometer, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1170 |