The following data is part of a premarket notification filed by Ge Medical Systems Lunar with the FDA for Encore 14 Software Release For The Ge Lunar Dxa Bone Densitometers.
| Device ID | K113286 |
| 510k Number | K113286 |
| Device Name: | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS |
| Classification | Densitometer, Bone |
| Applicant | GE MEDICAL SYSTEMS LUNAR 3030 Ohmeda Dr Madison, WI 53718 |
| Contact | Trishia Dwyer |
| Correspondent | Trishia Dwyer GE MEDICAL SYSTEMS LUNAR 3030 Ohmeda Dr Madison, WI 53718 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2012-04-27 |
| Summary: | summary |