Cleared Traditional

K905488 - DOPPLER UPGRADE FOR AUSONICS OPUS 1 REA...

K905488 is an FDA 510(k) clearance for DOPPLER UPGRADE FOR AUSONICS OPUS 1 REA..., manufactured by Ausonics Pty , Ltd.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K905488 · Ausonics Pty , Ltd. · Radiology device
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Dec 1991
Decision
376d
Days
Class 1
Risk

K905488 is an FDA 510(k) clearance for the DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Ausonics Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - 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. Elevated predicate reliance profile. 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 - K905488

510(k) Number K905488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date December 18, 1991
Days to Decision 376 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 107d · This submission: 376d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 11
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K905488.
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OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
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PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
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