Cleared Special

K092079 - MODIFICATION TO GE VIVID S5 AND S6 DIAG...

K092079 is an FDA 510(k) clearance for MODIFICATION TO GE VIVID S5 AND S6 DIAG..., manufactured by Ge Medical Systems Israel, Ultrasound, Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 28-day FDA review.

K092079 · Ge Medical Systems Israel, Ultrasound, Ltd. · Radiology device
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Aug 2009
Decision
28d
Days
Class 2
Risk

K092079 is an FDA 510(k) clearance for the MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND. 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 Medical Systems Israel, Ultrasound, Ltd. (Waukesha, US). The FDA issued a Cleared decision on August 6, 2009 after a review of 28 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 Medical Systems Israel, Ultrasound, Ltd. devices

FDA 510(k) Submission Details - K092079

510(k) Number K092079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2009
Decision Date August 06, 2009
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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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