Cleared Traditional

K142472 - Voluson E6 / Voluson E8 / Voluson E10 D...

K142472 is the FDA 510(k) clearance for Voluson E6 / Voluson E8 / Voluson E10 D... by Ge Healthcare. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K142472 · Ge Healthcare · Radiology device
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Feb 2015
Decision
160d
Days
Class 2
Risk

K142472 is an FDA 510(k) clearance for the Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems. 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 February 10, 2015 after a review of 160 days - an extended review 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: 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 K142472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date February 10, 2015
Days to Decision 160 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
53d slower than avg
Panel avg: 107d · This submission: 160d
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 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K142472.
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