The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Xgeo Gc80.
| Device ID | K123098 |
| 510k Number | K123098 |
| Device Name: | XGEO GC80 |
| Classification | System, X-ray, Stationary |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack SAMSUNG ELECTRONICS CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-02 |
| Decision Date | 2013-01-18 |
| Summary: | summary |