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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 K071966
Device Name 1.5T MRGFUS PELVIC COIL
Applicant
Insightec-Txsonics, Inc.
2777 N. Stemmons Freeway
Suite 940
Dallas,  TX  75207 -2273
Applicant Contact Nadir Alikacem
Correspondent
Insightec-Txsonics, Inc.
2777 N. Stemmons Freeway
Suite 940
Dallas,  TX  75207 -2273
Correspondent Contact Nadir Alikacem
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/16/2007
Decision Date 09/05/2007
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
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