Cleared Traditional

K151663 - RS80A Diagnostic Ultrasound System

K151663 is the FDA 510(k) clearance for RS80A 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 54-day FDA review.

K151663 · Samsung Medison Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
54d
Days
Class 2
Risk

K151663 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. (Gangnam-Gu, KR). The FDA issued a Cleared decision on August 12, 2015 after a review of 54 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 K151663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2015
Decision Date August 12, 2015
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K151663.
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
K152545 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
LOGIQ S8
K152195 · Ge Healthcare · Sep 2015
LOGIQ E9, LOGIQ E9 XDClear 2.0
K152309 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2015
Aplio 500/400/300 Diagnostic Ultrasound System V6.0
K151451 · Toshibamedical Systems Corporation · Jul 2015
LOGIQ e
K151028 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2015
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
K150080 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2015