Cleared Traditional

M2 WRIST MRI SYSTEM

K120701 · Aspect Imaging, Ltd. · Radiology
Feb 2013
Decision
337d
Days
Class 2
Risk

About This 510(k) Submission

K120701 is an FDA 510(k) clearance for the M2 WRIST MRI SYSTEM, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Aspect Imaging, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on February 7, 2013, 337 days after receiving the submission on March 7, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K120701 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2012
Decision Date February 07, 2013
Days to Decision 337 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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