Cleared Abbreviated

K183235 - SonoSite SII Ultrasound System

K183235 is the FDA 510(k) clearance for SonoSite SII Ultrasound System by FUJIFILM Sonosite, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K183235 · FUJIFILM Sonosite, Inc. · Radiology device
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Feb 2019
Decision
79d
Days
Class 2
Risk

K183235 is an FDA 510(k) clearance for the SonoSite SII 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 February 7, 2019 after a review of 79 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

Submission Details

510(k) Number K183235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2018
Decision Date February 07, 2019
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Standards-based clearance path. 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 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 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K183235.
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
K190206 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2019
Imagio Ultrasound Imaging System
K182628 · Seno Medical Instruments, Inc. · Mar 2019
RS85 Diagnostic Ultrasound System
K182932 · Samsung Medison Co., Ltd. · Feb 2019
X5 Series Digital Color Doppler Ultrasound System
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Venue GO
K183362 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2019
Aloka Arietta 850
K183456 · Hitachi Healthcare Americas · Jan 2019