The following data is part of a premarket notification filed by Samsung Electronics Co.,ltd. with the FDA for Gu60a & Gu60a-65.
| Device ID | K173828 |
| 510k Number | K173828 |
| 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 | Noh Jaesang |
| Correspondent | Noh Jaesang 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 | 2017-12-18 |
| Decision Date | 2018-01-12 |
| Summary: | summary |