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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 K103148
Device Name AIDA DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Panasonic Healthcare Co., Ltd.
2425 Squak Mountain Loop SW
Issaquah,  WA  98027
Applicant Contact RAM BEDI
Correspondent
Panasonic Healthcare Co., Ltd.
2425 Squak Mountain Loop SW
Issaquah,  WA  98027
Correspondent Contact RAM BEDI
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received10/25/2010
Decision Date 03/11/2011
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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