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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 K091536
Device Name OPTIMA MR450W
3200 n. grandview blvd.
waukesha,  WI  53188
Applicant Contact mark stauffer
Regulation Number892.1000
Classification Product Code
Date Received05/26/2009
Decision Date 07/17/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls