Cleared Traditional

K171048 - RS80A Diagnostic Ultrasound System

K171048 is an FDA 510(k) clearance for RS80A 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 139-day FDA review.

K171048 · Samsung Medison Co., Ltd. · Radiology device
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Aug 2017
Decision
139d
Days
Class 2
Risk

K171048 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 August 24, 2017 after a review of 139 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 - K171048

510(k) Number K171048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2017
Decision Date August 24, 2017
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
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 K171048.
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
K171233 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Sep 2017
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DUS-7000 Digital Color Doppler Ultrasound System
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Acclarix AX4 Diagnostic Ultrasound System
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ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
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ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
K172374 · Siemens Medical Solutions USA, Inc. · Aug 2017