The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gc85a.
| Device ID | K160997 |
| 510k Number | K160997 |
| Device Name: | GC85A |
| Classification | System, X-ray, Stationary |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si,, KR 443-742 |
| Contact | Chulsin Kim |
| Correspondent | Chulsin Kim SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si,, KR 443-742 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806088512266 | K160997 | 000 |
| 08806088512211 | K160997 | 000 |