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 | K181626 |
| 510k Number | K181626 |
| 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 | Chang Soeun |
| Correspondent | Chang Soeun 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 | 2018-06-20 |
| Decision Date | 2018-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08801643990107 | K181626 | 000 |
| 08801643990091 | K181626 | 000 |