Cleared Traditional

K120201 - GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K120201 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 Traditional 510(k) pathway after a 87-day FDA review.

K120201 · Ge Vingmed Ultrasound AS · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
87d
Days
Class 2
Risk

K120201 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 April 19, 2012 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K120201

510(k) Number K120201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2012
Decision Date April 19, 2012
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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