Cleared Traditional

K142474 - S12 Digital Color Doppler Ultrasound System

K142474 is an FDA 510(k) clearance for S12 Digital Color Doppler Ultrasound System, manufactured by Sonoscape Company Limited. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K142474 · Sonoscape Company Limited · Radiology device
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Dec 2014
Decision
107d
Days
Class 2
Risk

K142474 is an FDA 510(k) clearance for the S12 Digital Color Doppler 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 Sonoscape Company Limited (Shenzhen, CN). The FDA issued a Cleared decision on December 19, 2014 after a review of 107 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 Sonoscape Company Limited devices

FDA 510(k) Submission Details - K142474

510(k) Number K142474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date December 19, 2014
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
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 891
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K142474.
S22 Digital Color Doppler Ultrasound System
K142815 · Sonoscape Company Limited · Jan 2015
S9 Portable Digital Color Doppler Ultrasound System
K142710 · Sonoscape Company Limited · Jan 2015
TE7 Diagnostic Ultrasound System
K143472 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2015
H60 V2.00 Diagnostic Ultrasound System
K143264 · Samsung Medison Co., Ltd. · Dec 2014
WS80A Diagnostic Ultrasound System
K143089 · Samsung Medison Co., Ltd. · Nov 2014
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
K142197 · Konica Minolta, Inc. · Nov 2014