QXLink
System, Image Processing, Radiological
VIEWORKS CO., LTD.
The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Qxlink.
Pre-market Notification Details
| Device ID | K161113 |
| 510k Number | K161113 |
| Device Name: | QXLink |
| Classification | System, Image Processing, Radiological |
| 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. 800 ROOSEVELT STE 417 Irvine, CA 92620 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-20 |
| Decision Date | 2016-08-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809394330388 | K161113 | 000 |
Trademark Results [QXLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QXLINK 79262941 not registered Live/Pending |
Vieworks Co., Ltd. 2019-05-21 |
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