The following data is part of a premarket notification filed by Ge Lunar Corp. with the FDA for Dual-energy Vertebral Assessment View Software.
| Device ID | K023554 |
| 510k Number | K023554 |
| Device Name: | DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE |
| Classification | Densitometer, Bone |
| Applicant | GE LUNAR CORP. 726 HEARTLAND TRAIL Madison, WI 53717 |
| Contact | James P Raskob |
| Correspondent | James P Raskob GE LUNAR CORP. 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 | 2002-10-23 |
| Decision Date | 2002-12-20 |
| Summary: | summary |