Cleared Traditional

K162045 - SonoSite SII Ultrasound System

K162045 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 Traditional 510(k) pathway after a 24-day FDA review.

K162045 · FUJIFILM Sonosite, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
24d
Days
Class 2
Risk

K162045 is an FDA 510(k) clearance for the SonoSite SII Ultrasound System, SonoSite Edge II 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 August 18, 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 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 K162045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date August 18, 2016
Days to Decision 24 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
83d faster than avg
Panel avg: 107d · This submission: 24d
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 K162045.
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
K161843 · Toshibamedical Systems Corporation · Sep 2016
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
K162267 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2016
RS80A Diagnostic Ultrasound System
K162094 · Samsung Medison Co., Ltd. · Aug 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · Siemens Medical Solutions USA, Inc. · Jul 2016
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
K161359 · Esaote, S.P.A. · Jul 2016
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K161525 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2016