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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 K110151
Device Name ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
Original Applicant
22100 bothell everett highway
bothell,  WA  98021
Original Contact lynn harmer
Regulation Number892.1000
Classification Product Code
Date Received01/18/2011
Decision Date 03/22/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls