Cleared Traditional

K242511 - V5 Diagnostic Ultrasound System

K242511 is an FDA 510(k) clearance for V5 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 109-day FDA review.

K242511 · Samsung Medison Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
109d
Days
Class 2
Risk

K242511 is an FDA 510(k) clearance for the V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnos.... 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 December 10, 2024 after a review of 109 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 - K242511

510(k) Number K242511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2024
Decision Date December 10, 2024
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
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 870
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K242511.
Voluson Expert 18
K242168 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 2024
ULTIMUS Series Ultrasound Diagnostic System
K240676 · Vinno Technology (Suzhou) Co.,Ltd · Dec 2024
EPIQ Series Diagnostic Ultrasound System
K242020 · Philips Ultrasound, LLC · Dec 2024
Digital Color Doppler Ultrasound Imaging System (Readius L15)
K243132 · Shantou Institute of Ultrasonic Instruments Co., Ltd. · Dec 2024
HERA W10 Diagnostic Ultrasound System
K242444 · Samsung Medison Co., Ltd. · Nov 2024
ACUSON Sequoia Diagnostic Ultrasound System
K242523 · Siemens Medical Solutions USA, Inc. · Nov 2024