The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gc70.
| Device ID | K163115 |
| 510k Number | K163115 |
| Device Name: | GC70 |
| Classification | System, X-ray, Stationary |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, KR 16677 |
| Contact | Chulsin Kim |
| Correspondent | Chulsin Kim SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, KR 16677 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2016-12-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GC70 79181598 5143847 Live/Registered |
Hyundai Motor Company 2015-12-31 |