Quantib Brain

FDA 510(k) K173939 · Quantib B.V.

Substantially Equivalent

510(k) numberK173939

Submission

Device name
Quantib Brain
Applicant
Quantib B.V.
Rotterdam, NL
Received
December 26, 2017
Decision date
March 9, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Quantib Brain cleared by the FDA?

Quantib Brain (K173939) received a 510(k) decision of Substantially Equivalent on March 9, 2018, 73 days after the submission was received.

What is the product code of K173939?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.