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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 K202160
Device Name Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System
FUJIFILM SonoSite Inc.
21919 30th Dr SE
Bothell,  WA  98021 -3904
Applicant Contact Anoush Frankian
FUJIFILM SonoSite Inc.
21919 30th Dr SE
Bothell,  WA  98021 -3904
Correspondent Contact Anoush Frankian
Regulation Number892.1550
Classification Product Code
Subsequent Product Codes
Date Received08/03/2020
Decision Date 09/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No