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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K202035
Device Name Vscan Air
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
Primary Care Diagnostics, Llc
9900 W. Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received07/23/2020
Decision Date 11/20/2020
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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