Cleared Traditional

K181985 - Voluson E6

K181985 is the FDA 510(k) clearance for Voluson E6 by Ge Healthcare. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K181985 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
113d
Days
Class 2
Risk

K181985 is an FDA 510(k) clearance for the Voluson E6, Voluson E8, Voluson E10. 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 Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on November 15, 2018 after a review of 113 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 Ge Healthcare devices

Submission Details

510(k) Number K181985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2018
Decision Date November 15, 2018
Days to Decision 113 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
6d slower than avg
Panel avg: 107d · This submission: 113d
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
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K181985.
6420 Ultrasound System
K183191 · Esaote, S.P.A. · Dec 2018
Versana Premier
K182277 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 2018
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K182715 · Shenzhen Wisonic Medical Technology Co. , Ltd. · Nov 2018
Z6 Diagnostic Ultrasound System
K182603 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2018
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
K182857 · Philips Ultrasound, Inc. · Nov 2018
Vivid T8, Vivid T9
K181934 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Nov 2018