Cleared Traditional

SonoSite X-Porte Ultrasound System

K171437 · FUJIFILM Sonosite, Inc. · Radiology
Jun 2017
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K171437 is an FDA 510(k) clearance for the SonoSite X-Porte 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 June 12, 2017, 27 days after receiving the submission on May 16, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K171437 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2017
Decision Date June 12, 2017
Days to Decision 27 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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