Cleared Traditional

K153539 - RS80A Diagnostic Ultrasound System

K153539 is the FDA 510(k) clearance for RS80A 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 298-day FDA review.

K153539 · Samsung Medison Co., Ltd. · Radiology device
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Oct 2016
Decision
298d
Days
Class 2
Risk

K153539 is an FDA 510(k) clearance for the RS80A 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 October 3, 2016 after a review of 298 days - an extended review cycle.

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 K153539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2015
Decision Date October 03, 2016
Days to Decision 298 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
191d slower than avg
Panel avg: 107d · This submission: 298d
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 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K153539.
LOGIQ E9, LOGIQ E9 XDClear 2.0
K163077 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 2016
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MyLabSix CrystaLine
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Voluson E6, Voluson E8, Voluson E10
K162269 · Ge Healthcare · Oct 2016
Xario 100 Diagnostic Ultrasound System, V5.0
K162187 · Toshibamedical Systems Corporation · Sep 2016
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K162417 · Siemens Medi Cal Solutions, Inc. · Sep 2016