Cleared Traditional

K161168 - MyLabSix Ultrasound System

K161168 is an FDA 510(k) clearance for MyLabSix Ultrasound System, manufactured by Esaote Europe B.V.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K161168 · Esaote Europe B.V. · Radiology device
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Sep 2016
Decision
129d
Days
Class 2
Risk

K161168 is an FDA 510(k) clearance for the MyLabSix 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 Esaote Europe B.V. (Maastricht, NL). The FDA issued a Cleared decision on September 2, 2016 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Esaote Europe B.V. devices

FDA 510(k) Submission Details - K161168

510(k) Number K161168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2016
Decision Date September 02, 2016
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 107d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 922
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K161168.
SonoSite iViz Ultrasound System
K162288 · FUJIFILM Sonosite, Inc. · Sep 2016
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
K162243 · Siemens Medi Cal Solutions, Inc. · 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
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · FUJIFILM Sonosite, Inc. · Aug 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · Siemens Medical Solutions USA, Inc. · Jul 2016