Cleared Traditional

K171070 - WS80A Diagnostic Ultrasound System

K171070 is the FDA 510(k) clearance for WS80A Diagnostic Ultrasound System by Samsung Medison Co., Ltd.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K171070 · Samsung Medison Co., Ltd. · Radiology device
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Aug 2017
Decision
121d
Days
Class 2
Risk

K171070 is an FDA 510(k) clearance for the WS80A Diagnostic 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 Samsung Medison Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on August 9, 2017 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 Samsung Medison Co., Ltd. devices

Submission Details

510(k) Number K171070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date August 09, 2017
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.

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 788
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K171070.
RS80A Diagnostic Ultrasound System
K171048 · Samsung Medison Co., Ltd. · Aug 2017
Acclarix AX4 Diagnostic Ultrasound System
K171900 · Edan Instruments, Inc. · Aug 2017
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
K172374 · Siemens Medical Solutions USA, Inc. · Aug 2017
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