Cleared Traditional

Synq Software Version 1.3

K232981 · Synaptive Medical, Inc. · Radiology
Oct 2023
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K232981 is an FDA 510(k) clearance for the Synq Software Version 1.3, 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 October 11, 2023, 20 days after receiving the submission on September 21, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K232981 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2023
Decision Date October 11, 2023
Days to Decision 20 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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