The following data is part of a premarket notification filed by Samsung Electronics Co.,ltd. with the FDA for Gc70, Gu60a&gu60a-65, Gf50, Gf50a, Gr40cw, And Gm85.
| Device ID | K180543 |
| 510k Number | K180543 |
| Device Name: | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, And GM85 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-05-24 |
| Summary: | summary |