Cleared Special

K131514 - GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGI...

K131514 is an FDA 510(k) clearance for GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGI..., manufactured by Ge Vingmed Ultrasound AS. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 45-day FDA review.

K131514 · Ge Vingmed Ultrasound AS · Radiology device
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Jul 2013
Decision
45d
Days
Class 2
Risk

K131514 is an FDA 510(k) clearance for the GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING 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 Vingmed Ultrasound AS (Wauwatosa, US). The FDA issued a Cleared decision on July 12, 2013 after a review of 45 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 Vingmed Ultrasound AS devices

FDA 510(k) Submission Details - K131514

510(k) Number K131514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date July 12, 2013
Days to Decision 45 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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

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