Cleared Traditional

K181336 - HS50 / HS60 Diagnostic Ultrasound System

K181336 is an FDA 510(k) clearance for HS50 / HS60 Diagnostic Ultrasound System, manufactured by Samsung Medison Co., Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K181336 · Samsung Medison Co., Ltd. · Radiology device
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Dec 2018
Decision
197d
Days
Class 2
Risk

K181336 is an FDA 510(k) clearance for the HS50 / HS60 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. (Hongcheon-Gun, KR). The FDA issued a Cleared decision on December 4, 2018 after a review of 197 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

FDA 510(k) Submission Details - K181336

510(k) Number K181336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date December 04, 2018
Days to Decision 197 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
90d slower than avg
Panel avg: 107d · This submission: 197d
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 1097
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K181336.
Color Doppler Ultrasound System
K182165 · Shenzhen Well.D Medical Electronics Co., Ltd. · Dec 2018
HERA W10 Diagnostic Ultrasound System
K182595 · Samsung Medison Co., Ltd. · Dec 2018
Vivid iq
K181727 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 2018
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Versana Premier
K182277 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 2018
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K182715 · Shenzhen Wisonic Medical Technology Co. , Ltd. · Nov 2018