Cleared Traditional

K091877 - CHISON DIGITAL COLOR DOPPLER ULTRASOUND...

K091877 is the FDA 510(k) clearance for CHISON DIGITAL COLOR DOPPLER ULTRASOUND... by Chison Medical Imaging Co., Ltd.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K091877 · Chison Medical Imaging Co., Ltd. · Radiology device
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Sep 2009
Decision
71d
Days
Class 2
Risk

K091877 is an FDA 510(k) clearance for the CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, P.... Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Chison Medical Imaging Co., Ltd. (Dublin, US). The FDA issued a Cleared decision on September 2, 2009 after a review of 71 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 Chison Medical Imaging Co., Ltd. devices

Submission Details

510(k) Number K091877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date September 02, 2009
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 189
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