Cleared Traditional

K182632 - HS30 Diagnostic Ultrasound System

K182632 is the FDA 510(k) clearance for HS30 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 106-day FDA review.

K182632 · Samsung Medison Co., Ltd. · Radiology device
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Jan 2019
Decision
106d
Days
Class 2
Risk

K182632 is an FDA 510(k) clearance for the HS30 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 January 8, 2019 after a review of 106 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 K182632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date January 08, 2019
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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 K182632.
HM70A Diagnostic Ultrasound System
K182894 · Samsung Medison Co., Ltd. · Jan 2019
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
K182636 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2019
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K181637 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2019
minisono
K182845 · Alpinion Medical Systems Co., Ltd. · Dec 2018
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