Cleared Abbreviated

K162288 - SonoSite iViz Ultrasound System

K162288 is an FDA 510(k) clearance for SonoSite iViz Ultrasound System, manufactured by FUJIFILM Sonosite, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Abbreviated 510(k) pathway after a 24-day FDA review.

K162288 · FUJIFILM Sonosite, Inc. · Radiology device
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Sep 2016
Decision
24d
Days
Class 2
Risk

K162288 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 September 8, 2016 after a review of 24 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all FUJIFILM Sonosite, Inc. devices

FDA 510(k) Submission Details - K162288

510(k) Number K162288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2016
Decision Date September 08, 2016
Days to Decision 24 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

IYN Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 1085
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K162288.
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