Cleared Traditional

K142815 - S22 Digital Color Doppler Ultrasound System

K142815 is an FDA 510(k) clearance for S22 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 121-day FDA review.

K142815 · Sonoscape Company Limited · Radiology device
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Jan 2015
Decision
121d
Days
Class 2
Risk

K142815 is an FDA 510(k) clearance for the S22 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 January 28, 2015 after a review of 121 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 - K142815

510(k) Number K142815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2014
Decision Date January 28, 2015
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
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 K142815.
ACUSON P500 Diagnostic Ultrasound System
K150050 · Siemens Medical Solutions USA, Inc. · Feb 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
K142714 · Sonoscape Company Limited · Jan 2015
LOGIQ P9, LOGIQ P7
K143452 · Ge Healthcare · 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
S12 Digital Color Doppler Ultrasound System
K142474 · Sonoscape Company Limited · Dec 2014