FDA 510(K) K180995, Vscan Extend
FDA 510(K) K180995, Vscan Extend
Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K180995
Device Name Vscan Extend
Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics
Regulation Number 892.1550
Classification Product Code IYN
Subsequent Product Codes ITX IYO
Date Received 04/16/2018
Decision Date 06/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
Total pages: 1422
Fully redacted pages: 1196
Content pages: 226
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