The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Vivix-s 1012n.
| Device ID | K152855 |
| 510k Number | K152855 |
| Device Name: | VIVIX-S 1012N |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VIEWORKS CO., LTD. (GWANYANG-DONG) 41-3, BURIM-RO 170BEON-GIL, Anyang-si, KR 431-060 |
| Contact | Yoonjae Im |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809394330173 | K152855 | 000 |
| 08809394330166 | K152855 | 000 |