X-Ray Vva
FDA 510(k) K112807 · Medis Medical Imaging Systems BV
510(k) numberK112807
Submission
- Device name
- X-Ray Vva
- Applicant
- Medis Medical Imaging Systems BV
Leiden, NL - Received
- September 27, 2011
- Decision date
- February 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was X-Ray Vva cleared by the FDA?
X-Ray Vva (K112807) received a 510(k) decision of Substantially Equivalent on February 27, 2012, 153 days after the submission was received.
What is the product code of K112807?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.