The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gc70, Gu60a, Gu60a-65, Gf50, Gr50a ; Gr40cw ; Gm85 ; Gc85a.
| Device ID | K182183 |
| 510k Number | K182183 |
| Device Name: | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A |
| 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 |
| Subsequent Product Code | IZL |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2018-12-07 |
| Summary: | summary |