Cleared Traditional

K192505 - HS50/HS60 Diagnostics Ultrasound System

K192505 is an FDA 510(k) clearance for HS50/HS60 Diagnostics 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 91-day FDA review.

K192505 · Samsung Medison Co., Ltd. · Radiology device
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Dec 2019
Decision
91d
Days
Class 2
Risk

K192505 is an FDA 510(k) clearance for the HS50/HS60 Diagnostics 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 12, 2019 after a review of 91 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

FDA 510(k) Submission Details - K192505

510(k) Number K192505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2019
Decision Date December 12, 2019
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
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 K192505.
RS85 Diagnostic Ultrasound System
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ZS3 and z.one pro Ultrasound Systems
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DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
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HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
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Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
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