Cleared Traditional

Wrist 3

K160185 · Aspect Imaging, Ltd. · Radiology
Mar 2016
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K160185 is an FDA 510(k) clearance for the Wrist 3, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Aspect Imaging, Ltd. (Industrial Area Hevel Modi?In., IL). The FDA issued a Cleared decision on March 1, 2016, 34 days after receiving the submission on January 27, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K160185 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2016
Decision Date March 01, 2016
Days to Decision 34 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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