The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Qxlink.
| Device ID | K092081 |
| 510k Number | K092081 |
| Device Name: | QXLINK |
| Classification | System, Image Processing, Radiological |
| Applicant | VIEWORKS CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Marc Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-09 |
| Decision Date | 2009-07-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QXLINK 79262941 not registered Live/Pending |
Vieworks Co., Ltd. 2019-05-21 |