Cleared Special

K101149 - GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGI...

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)
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.

View all Ge Vingmed Ultrasound AS devices

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 490
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K101149.
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K111706 · Volcano Corporation · Jul 2011
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K111435 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2011
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K102991 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2010
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
K101337 · Sonoscape Company Limited · Sep 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
K093466 · Hitachi Medical Systems America, Inc. · Jun 2010
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · Aloka Co., Ltd. · Nov 2009