Cleared Traditional

K102989 - OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102989 · Chang Gung Medical Technology Co., Ltd. Linkou Fac · Radiology device
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Dec 2010
Decision
64d
Days
Class 2
Risk

K102989 is an FDA 510(k) clearance for the OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS. 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 Chang Gung Medical Technology Co., Ltd. Linkou Fac (Dublin, US). The FDA issued a Cleared decision on December 9, 2010 after a review of 64 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 Chang Gung Medical Technology Co., Ltd. Linkou Fac devices

Submission Details

510(k) Number K102989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2010
Decision Date December 09, 2010
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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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