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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 K101337
Device Name A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
Applicant
Sonoscape Company Limited
5d, #19 Ln. 999, Zhongshan
Rd. 9s-2)
Shanghai,  CN 20030
Applicant Contact Diana Hong
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received05/12/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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