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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K111060
Device Name MRGFUS PELVIC PA COIL MODEL 1.0
Original Applicant
INSIGHTECH, LTD
5 nahum heth st.
tirat carmel,  IL 39120
Original Contact ori lubin
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/18/2011
Decision Date 09/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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