Cleared Special

K101149 - GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K101149 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 IYO cleared through the Special 510(k) pathway after a 173-day FDA review.

K101149 · Ge Vingmed Ultrasound AS · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
173d
Days
Class 2
Risk

K101149 is an FDA 510(k) clearance for the GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ge Vingmed Ultrasound AS (Wauwatosa, US). The FDA issued a Cleared decision on October 13, 2010 after a review of 173 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K101149

510(k) Number K101149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2010
Decision Date October 13, 2010
Days to Decision 173 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
66d slower than avg
Panel avg: 107d · This submission: 173d
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 760
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