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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 K141945
Device Name ECHOSTAR COMFORT 1.5T MRI
Applicant
Alltech Medical Systems America, Inc.
28900 Fountain Pkwy.
Solon,  OH  44139
Applicant Contact MICHAELEEN DOM
Correspondent
Alltech Medical Systems America, Inc.
28900 Fountain Pkwy.
Solon,  OH  44139
Correspondent Contact MICHAELEEN DOM
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/17/2014
Decision Date 02/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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