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 |