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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 K161588
Device Name Vscan Extend
Applicant
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
9900 W. INNOVATION DRIVE
WAUWATOSA,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
9900 W. INNOVATION DRIVE
WAUWATOSA,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/08/2016
Decision Date 08/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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