The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gu60a, Gu60a-65.
| Device ID | K182622 |
| 510k Number | K182622 |
| Device Name: | GU60A, GU60A-65 |
| Classification | System, X-ray, Stationary |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, KR 16677 |
| Contact | Jaesang Noh |
| Correspondent | Jaesang Noh 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2018-10-23 |
| Summary: | summary |