The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Lunar Frax 10-year Fracture Risk Software Option.
| Device ID | K082317 |
| 510k Number | K082317 |
| Device Name: | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION |
| Classification | Densitometer, Bone |
| Applicant | GENERAL ELECTRIC CO. 726 HEARTLAND TRAIL Madison, WI 53717 |
| Contact | James P Raskob |
| Correspondent | James P Raskob GENERAL ELECTRIC CO. 726 HEARTLAND TRAIL Madison, WI 53717 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2008-09-26 |
| Summary: | summary |