Cleared Traditional

Sonosite PX Ultrasound System

K213763 · FUJIFILM Sonosite, Inc. · Radiology
Dec 2021
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K213763 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 December 27, 2021, 26 days after receiving the submission on December 1, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K213763 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2021
Decision Date December 27, 2021
Days to Decision 26 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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