Cleared Traditional

K142472 - Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems

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

K142472 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K142472

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.

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 1102
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K142472.
ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
K150249 · Zonare Medical Systems, Inc. · Mar 2015
U50 Diagnostic Ultrasound System
K142511 · Edan Instruments, Inc. · Feb 2015
Terason uSmart3300 Ultrasound System
K150148 · Teratech Corp. · Feb 2015
ACUSON P500 Diagnostic Ultrasound System
K150050 · Siemens Medical Solutions USA, Inc. · Feb 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
K142714 · Sonoscape Company Limited · Jan 2015
LOGIQ P9, LOGIQ P7
K143452 · Ge Healthcare · Jan 2015