Cleared Traditional

K230084 - HERA W10 Diagnostic Ultrasound System

Also marketed or referenced as:
HERA W9 Diagnostic Ultrasound System

K230084 is the FDA 510(k) clearance for HERA W10 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 100-day FDA review.

K230084 · Samsung Medison Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
100d
Days
Class 2
Risk

K230084 is an FDA 510(k) clearance for the HERA W10 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 April 21, 2023 after a review of 100 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

Submission Details

510(k) Number K230084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2023
Decision Date April 21, 2023
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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 K230084.
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
K230768 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2023
EPIQ Series Diagnostic Ultrasound System
K231190 · Philips Ultrasound, LLC · May 2023
Lumify Diagnostic Ultrasound System
K223771 · Philips Ultrasound · May 2023
X-CUBE 50, X-CUBE 60
K223564 · Alpinion Medical Systems Co., Ltd. · Apr 2023
Ultrasound System 2300
K223830 · Bk Medical Aps · Apr 2023
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
K223017 · Canon Medical Systems Corporation · Mar 2023