Cleared Traditional

Sonosite PX Ultrasound System

K200964 · FUJIFILM Sonosite, Inc. · Radiology
May 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K200964 is an FDA 510(k) clearance for the Sonosite PX 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 May 8, 2020, 28 days after receiving the submission on April 10, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K200964 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2020
Decision Date May 08, 2020
Days to Decision 28 days
Submission Type Traditional
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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