Cleared Traditional

K110020 - TERASON T3200 ULTRASOUND SYSTEM

K110020 is an FDA 510(k) clearance for TERASON T3200 ULTRASOUND SYSTEM, manufactured by Teratech Corp.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K110020 · Teratech Corp. · Radiology device
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Jan 2011
Decision
17d
Days
Class 2
Risk

K110020 is an FDA 510(k) clearance for the TERASON T3200 ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Teratech Corp. (Burlington, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Teratech Corp. devices

FDA 510(k) Submission Details - K110020

510(k) Number K110020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date January 20, 2011
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 240
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