Cleared Special

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

K202160 · FUJIFILM Sonosite, Inc. · Radiology
Sep 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K202160 is an FDA 510(k) clearance for the 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, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on September 1, 2020, 29 days after receiving the submission on August 3, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K202160 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2020
Decision Date September 01, 2020
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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