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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K232981
Device Name Synq Software Version 1.3
Applicant
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto,  CA M5V 3B1
Applicant Contact Ahmed Hamed
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/21/2023
Decision Date 10/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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