Cleared Special

K152567 - Voluson E6

K152567 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 Special 510(k) pathway after a 58-day FDA review.

K152567 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
58d
Days
Class 2
Risk

K152567 is an FDA 510(k) clearance for the Voluson E6, Voluson E8, Voluson E10 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 Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on November 6, 2015 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Healthcare devices

Submission Details

510(k) Number K152567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2015
Decision Date November 06, 2015
Days to Decision 58 days
Submission Type Special
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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 K152567.
HM70A Diagnostic Ultrasound System
K153408 · Samsung Medison Co., Ltd. · Dec 2015
Touch Ultrasound
K152467 · Carestream Health, Inc. · Dec 2015
Venue 50
K152758 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 2015
HS70A Diagnostic Ultrasound System
K152962 · Samsung Medison Co., Ltd. · Nov 2015
M9/M9CV/M9T Diagnostic Ultrasound System
K152543 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
K152763 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015