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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K173290
Device Name DuoFLEX Coil Suite
Applicant
MR Instruments, Inc
5610 Rowland Road, Suite 145
Minnetonka,  MN  55343
Applicant Contact Leon Ricord
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/16/2017
Decision Date 11/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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