Mri-Q System

FDA 510(k) K111222 · Resonance Health Analysis Services Pty, Ltd.

Substantially Equivalent

510(k) numberK111222

Submission

Device name
Mri-Q System
Applicant
Resonance Health Analysis Services Pty, Ltd.
Irvine, CA, US
Received
May 2, 2011
Decision date
July 28, 2011
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 Mri-Q System cleared by the FDA?

Mri-Q System (K111222) received a 510(k) decision of Substantially Equivalent on July 28, 2011, 87 days after the submission was received.

What is the product code of K111222?

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