Cleared Traditional

K102989 - OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

K102989 is an FDA 510(k) clearance for OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRA..., manufactured by Chang Gung Medical Technology Co., Ltd. Linkou Fac. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 64-day FDA review.

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

FDA 510(k) Submission Details - K102989

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.

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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