Cleared Traditional

K210959 - RS85 Diagnostic Ultrasound System

K210959 is the FDA 510(k) clearance for RS85 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 85-day FDA review.

K210959 · Samsung Medison Co., Ltd. · Radiology device
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Jun 2021
Decision
85d
Days
Class 2
Risk

K210959 is an FDA 510(k) clearance for the RS85 Diagnostic Ultrasound System, RS80 EVO 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 June 24, 2021 after a review of 85 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 K210959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2021
Decision Date June 24, 2021
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
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
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