The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagn with the FDA for Encore Version 16 Software For Ge Lunar Dxa Bone Densitometers.
| Device ID | K133664 |
| 510k Number | K133664 |
| Device Name: | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS |
| Classification | Densitometer, Bone |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN 3030 OHMEDA DRIVE Madison, WI 53718 -6704 |
| Contact | Chris Paulik |
| Correspondent | Chris Paulik GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN 3030 OHMEDA DRIVE Madison, WI 53718 -6704 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-29 |
| Decision Date | 2014-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682138352 | K133664 | 000 |
| 00840682138345 | K133664 | 000 |
| 00840682117142 | K133664 | 000 |
| 00840682117098 | K133664 | 000 |