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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 Doppler, Ultrasonic
510(k) Number K113612
Device Name AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/06/2011
Decision Date 02/10/2012
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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