Cleared Traditional

K161119 - SonoSite iViz Ultrasound System

K161119 is the FDA 510(k) clearance for SonoSite iViz Ultrasound System by FUJIFILM Sonosite, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K161119 · FUJIFILM Sonosite, Inc. · Radiology device
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May 2016
Decision
23d
Days
Class 2
Risk

K161119 is an FDA 510(k) clearance for the SonoSite iViz Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on May 13, 2016 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all FUJIFILM Sonosite, Inc. devices

Submission Details

510(k) Number K161119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2016
Decision Date May 13, 2016
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 780
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K161119.
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · Siemens Medical Solutions USA, Inc. · Jul 2016
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TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K161525 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2016
LOGIQ P9 and LOGIQ P7
K161047 · Ge Healthcare · May 2016
6200 Ultrasound System and 6250 Ultrasound System
K153277 · Esaote, S.P.A. · May 2016
Voluson P6, Voluson P8
K160162 · Ge Healthcare · Apr 2016