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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 K113511
Device Name ECHOSTAR SPICA 1.5T MR SYSTEM
Applicant
Alltech Medical Systems America, Inc.
6551 Cochran Rd.
Solon,  OH  44139
Applicant Contact MICHAELEEN DOM
Correspondent
Alltech Medical Systems America, Inc.
6551 Cochran Rd.
Solon,  OH  44139
Correspondent Contact MICHAELEEN DOM
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/28/2011
Decision Date 05/02/2012
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
Recalls CDRH Recalls
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