Cleared Traditional

K243702 - V8 Diagnostic Ultrasound System

Also marketed or referenced as:
cV8 Diagnostic Ultrasound System V7 Diagnostic Ultrasound System cV7 Diagnostic Ultrasound System V6 Diagnostic Ultrasound System cV6 Diagnostic Ultrasound System

K243702 is the FDA 510(k) clearance for V8 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 75-day FDA review.

K243702 · Samsung Medison Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
75d
Days
Class 2
Risk

K243702 is an FDA 510(k) clearance for the V8 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 February 12, 2025 after a review of 75 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 K243702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2024
Decision Date February 12, 2025
Days to Decision 75 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 faster than avg
Panel avg: 107d · This submission: 75d
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 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K243702.
Digital Color Doppler Ultrasound Imaging System (Apogee C1)
K243178 · Shantou Institute of Ultrasonic Instruments Co., Ltd. · Mar 2025
NUSONO Handheld Ultrasound Scanner (NUSONO-C35)
K242681 · Nurodata, Inc. · Feb 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
K250214 · Edan Instruments, Inc. · Feb 2025
Vivid iq
K243620 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025
Vivid T9/Vivid T8
K243628 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025
EPIQ Series Diagnostic Ultrasound System
K243794 · Philips Ultrasound, LLC · Feb 2025