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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
Applicant
Insightech, Ltd.
5 Nahum Heth St.
Tirat Carmel, Park High-Tech North,  IL 39120
Applicant Contact ORI LUBIN
Correspondent
Insightech, Ltd.
5 Nahum Heth St.
Tirat Carmel, Park High-Tech North,  IL 39120
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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