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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 K132381
Device Name CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
Applicant
Clearmri Solutions, Inc.
W315 S3283 Harvest View Dr.
Waukesha,  WI  53189
Applicant Contact MARY ANN FERGUSON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/31/2013
Decision Date 04/04/2014
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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