Cleared Traditional

K933916 - AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER

K933916 is an FDA 510(k) clearance for AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER, manufactured by Ausonics Pty , Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 418-day FDA review.

K933916 · Ausonics Pty , Ltd. · Radiology device
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Oct 1994
Decision
418d
Days
Class 2
Risk

K933916 is an FDA 510(k) clearance for the AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER. 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 Ausonics Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Ausonics Pty , Ltd. devices

FDA 510(k) Submission Details - K933916

510(k) Number K933916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date October 03, 1994
Days to Decision 418 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
311d slower than avg
Panel avg: 107d · This submission: 418d
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

All 794
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