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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K161342
Device Name Sonic Window
Applicant
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact MICHAEL J. DOYLE
Correspondent
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact MICHAEL J. DOYLE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received05/13/2016
Decision Date 06/15/2016
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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