Cleared Traditional

K210068 - HS50 Diagnostic Ultrasound System

K210068 is the FDA 510(k) clearance for HS50 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 88-day FDA review.

K210068 · Samsung Medison Co., Ltd. · Radiology device
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Apr 2021
Decision
88d
Days
Class 2
Risk

K210068 is an FDA 510(k) clearance for the HS50 Diagnostic Ultrasound System, 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 April 9, 2021 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Samsung Medison Co., Ltd. devices

Submission Details

510(k) Number K210068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2021
Decision Date April 09, 2021
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 786
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K210068.
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System
K210699 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2021
Vivid S60N / Vivid S70N
K211216 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2021
HS40 Diagnostic Ultrasound System
K210426 · Samsung Medison Co., Ltd. · May 2021
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System
K202785 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Apr 2021
ACUSON Redwood Diagnostic Ultrasound System
K210743 · Siemens Medical Solutions USA, Inc. · Apr 2021
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
K203391 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2021