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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 K171824
Device Name Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
Applicant
Edan Instruments, Inc.
#15 Jinhui Rd.,Jinsha Community, Kengzi Sub-District
Pingshan District
Shenzhen,  CN 518067
Applicant Contact Alice Yang
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 Received06/19/2017
Decision Date 07/18/2017
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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