Cleared Special

K102393 - VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM

Also marketed or referenced as:
VIVID S6 DIAGNOSTICULTRASOUND SYSTEM

K102393 is an FDA 510(k) clearance for VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Ge Medical System Israel , Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 74-day FDA review.

K102393 · Ge Medical System Israel , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
74d
Days
Class 2
Risk

K102393 is an FDA 510(k) clearance for the VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ge Medical System Israel , Ltd. (Wauwatosa, US). The FDA issued a Cleared decision on November 5, 2010 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 System Israel , Ltd. devices

FDA 510(k) Submission Details - K102393

510(k) Number K102393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2010
Decision Date November 05, 2010
Days to Decision 74 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
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 506
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