Cleared Traditional

M2 WRIST 2 MRI SYSTEM

K130692 · Aspect Imaging, Ltd. · Radiology
Jan 2014
Decision
307d
Days
Class 2
Risk

About This 510(k) Submission

K130692 is an FDA 510(k) clearance for the M2 WRIST 2 MRI SYSTEM, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Aspect Imaging, Ltd. (Somerset, US). The FDA issued a Cleared decision on January 14, 2014, 307 days after receiving the submission on March 13, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K130692 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2013
Decision Date January 14, 2014
Days to Decision 307 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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