Cleared Traditional

K143601 - U-Lite

K143601 is an FDA 510(k) clearance for U-Lite, manufactured by Sonoscanner Sarl. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K143601 · Sonoscanner Sarl · Radiology device
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Mar 2015
Decision
90d
Days
Class 2
Risk

K143601 is an FDA 510(k) clearance for the U-Lite. 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 Sarl (Paris, FR). The FDA issued a Cleared decision on March 18, 2015 after a review of 90 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 Sonoscanner Sarl devices

FDA 510(k) Submission Details - K143601

510(k) Number K143601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date March 18, 2015
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 895
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K143601.
S30/S40 Digital Color Doppler Ultraound System
K150045 · Sonoscape Company Limited · Apr 2015
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
K150204 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2015
A35 Diagnostic Ultrasound System
K150478 · Samsung Medison Co., Ltd. · Mar 2015
U50 Diagnostic Ultrasound System
K142511 · Edan Instruments, Inc. · Feb 2015
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
K142472 · Ge Healthcare · Feb 2015
ACUSON P500 Diagnostic Ultrasound System
K150050 · Siemens Medical Solutions USA, Inc. · Feb 2015