Cleared Traditional

K101008 - DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

K101008 is an FDA 510(k) clearance for DIGITAL COLOR DOPPLER ULTRASOUND IMAGIN..., manufactured by Shantou Institute of Ultrasonic Instruments (Siui. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K101008 · Shantou Institute of Ultrasonic Instruments (Siui · Radiology device
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Jun 2010
Decision
57d
Days
Class 2
Risk

K101008 is an FDA 510(k) clearance for the DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LIN.... Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Shantou Institute of Ultrasonic Instruments (Siui (Dublin, US). The FDA issued a Cleared decision on June 8, 2010 after a review of 57 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 Shantou Institute of Ultrasonic Instruments (Siui devices

FDA 510(k) Submission Details - K101008

510(k) Number K101008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2010
Decision Date June 08, 2010
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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