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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 K161300
Device Name Acclarix AX8 Diagnostic Ultrasound System
Applicant
Edan Instruments, Inc.
3/F - B, Nanshan Medical Equipments Park
Nanhai Rd. 1019#
Shenzhen,  CN 518067
Applicant Contact ERICO LI
Correspondent
Edan Medical
1200 Crossman Ave.
Suite 200
Sunnyvale,  CA  94089
Correspondent Contact DOUG WORTH
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received05/09/2016
Decision Date 05/31/2016
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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