Sonosite PX Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

FUJIFILM SonoSite, Inc.

The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite Px Ultrasound System.

Pre-market Notification Details

Device IDK200964
510k NumberK200964
Device Name:Sonosite PX Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell,  WA  98021 -3904
ContactSudipta Chakrabarti
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-04-10
Decision Date2020-05-08

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