The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Vivix-s 1717v.
| Device ID | K181003 |
| 510k Number | K181003 |
| Device Name: | VIVIX-S 1717V |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Vieworks Co., Ltd. (Gwanyang-dong) 41-3, Burim-ro 170beon-gil, Dongan-gu Anyang-si, KR 431-060 |
| Contact | Jordin Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-05-15 |
| Summary: | summary |