Quantib Brain 1.2
FDA 510(k) K163013 · Quantib B.V.
510(k) numberK163013
Submission
- Device name
- Quantib Brain 1.2
- Applicant
- Quantib B.V.
Rotterdam, NL - Received
- October 28, 2016
- Decision date
- January 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Quantib Brain 1.2 cleared by the FDA?
Quantib Brain 1.2 (K163013) received a 510(k) decision of Substantially Equivalent on January 6, 2017, 70 days after the submission was received.
What is the product code of K163013?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.