Cleared Traditional

K003479 - U-SYSTEMS ULTRASOUND SYSTEM USI-2000

K003479 is an FDA 510(k) clearance for U-SYSTEMS ULTRASOUND SYSTEM USI-2000, manufactured by U-Systems, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K003479 · U-Systems, Inc. · Radiology device
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Jan 2001
Decision
70d
Days
Class 2
Risk

K003479 is an FDA 510(k) clearance for the U-SYSTEMS ULTRASOUND SYSTEM USI-2000. 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 U-Systems, Inc. (Los Altos,, US). The FDA issued a Cleared decision on January 18, 2001 after a review of 70 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. 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.

View all U-Systems, Inc. devices

FDA 510(k) Submission Details - K003479

510(k) Number K003479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2000
Decision Date January 18, 2001
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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