The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagnostics,llc with the FDA for Ge Lunar Dxa Bone Densitometers With Encore Version 17.
| Device ID | K161682 |
| 510k Number | K161682 |
| Device Name: | GE Lunar DXA Bone Densitometers With EnCORE Version 17 |
| Classification | Densitometer, Bone |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC 3030 OHMEDA DRIVE Madison, WI 53718 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC 3030 OHMEDA DRIVE 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 | 2016-06-17 |
| Decision Date | 2016-12-02 |
| Summary: | summary |