The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Xgeo Gc80.
| Device ID | K140334 |
| 510k Number | K140334 |
| Device Name: | XGEO GC80 |
| Classification | System, X-ray, Stationary |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443742 |
| Contact | Chulsin Kim |
| Correspondent | Chulsin Kim SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443742 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-05-28 |
| Summary: | summary |