Cleared Traditional

Evry

K200327 · Synaptive Medical, Inc. · Radiology
Apr 2020
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K200327 is an FDA 510(k) clearance for the Evry, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on April 29, 2020, 79 days after receiving the submission on February 10, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K200327 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2020
Decision Date April 29, 2020
Days to Decision 79 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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