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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K122921
Device Name C1-6-D ULTRASOUND TRANSDUCER
Applicant
GE Healthcare
9900 W. Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE Healthcare
9900 W. Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.1570
Classification Product Code
ITX  
Date Received09/24/2012
Decision Date 10/05/2012
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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