The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Digital Diagnostic Mobile X-ray System.
| Device ID | K162278 |
| 510k Number | K162278 |
| Device Name: | Digital Diagnostic Mobile X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, KR 16677 |
| Contact | Chulsin Kim |
| Correspondent | Chulsin Kim SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, KR 16677 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-15 |
| Decision Date | 2016-11-15 |
| Summary: | summary |