Qxlink
FDA 510(k) K092081 · Vieworks Co., Ltd.
510(k) numberK092081
Submission
- Device name
- Qxlink
- Applicant
- Vieworks Co., Ltd.
Flintville, TN, US - Received
- July 9, 2009
- Decision date
- July 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Qxlink cleared by the FDA?
Qxlink (K092081) received a 510(k) decision of Substantially Equivalent on July 21, 2009, 12 days after the submission was received.
What is the product code of K092081?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.