Cleared Traditional

K920307 - AUSONICS OPUS 1 SYSTEM

K920307 is an FDA 510(k) clearance for AUSONICS OPUS 1 SYSTEM, manufactured by Ausonics Pty , Ltd.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K920307 · Ausonics Pty , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
117d
Days
Class 2
Risk

K920307 is an FDA 510(k) clearance for the AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Ausonics Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on May 19, 1992 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ausonics Pty , Ltd. devices

FDA 510(k) Submission Details - K920307

510(k) Number K920307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1992
Decision Date May 19, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 107d · This submission: 117d
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

All 205
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K920307.
LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE
K915860 · Biosound, Inc. · Jul 1992
ACUSON C366 TRANSDUCER
K911916 · Acuson Corp. · Jun 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
K921036 · Hewlett-Packard Co. · May 1992
SACA, 3.5 MHZ PROBE
K905200 · Diasonics, Inc. · Apr 1992
BIPLANE TRANSRECTAL PROBE
K914006 · Biosound, Inc. · Apr 1992
SONOLAYER ALPHA, MODEL SSH-140A
K913798 · Toshiba America Medical Systems, In.C · Apr 1992