Cleared Traditional

K171164 - U-Lite EXP

K171164 is the FDA 510(k) clearance for U-Lite EXP by Sonoscanner. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K171164 · Sonoscanner · Radiology device
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Aug 2017
Decision
105d
Days
Class 2
Risk

K171164 is an FDA 510(k) clearance for the U-Lite EXP. 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 Sonoscanner (Ivry Sur Seine, FR). The FDA issued a Cleared decision on August 3, 2017 after a review of 105 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.

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Submission Details

510(k) Number K171164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2017
Decision Date August 03, 2017
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K171164.
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
K172374 · Siemens Medical Solutions USA, Inc. · Aug 2017
WS80A Diagnostic Ultrasound System
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HS40 Diagnostic Ultrasound System
K172129 · Samsung Medison Co., Ltd. · Aug 2017
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
K171034 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2017
Vivid E80, Vivid E90, Vivid E95
K170823 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2017
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
K163702 · Toshibamedical Systems Corporation · May 2017