Qxlink
FDA 510(k) K132302 · Vieworks Co., Ltd.
510(k) numberK132302
Submission
- Device name
- Qxlink
- Applicant
- Vieworks Co., Ltd.
Anaheim, CA, US - Received
- July 24, 2013
- Decision date
- September 12, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Qxlink cleared by the FDA?
Qxlink (K132302) received a 510(k) decision of Substantially Equivalent on September 12, 2013, 50 days after the submission was received.
What is the product code of K132302?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.