Cleared Traditional

K080555 - SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)

K080555 is an FDA 510(k) clearance for SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND ..., manufactured by Ivu Imaging Corporation. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K080555 · Ivu Imaging Corporation · Radiology device
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Jun 2008
Decision
96d
Days
Class 2
Risk

K080555 is an FDA 510(k) clearance for the SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS). Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Ivu Imaging Corporation (Grapevine, US). The FDA issued a Cleared decision on June 3, 2008 after a review of 96 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 Ivu Imaging Corporation devices

FDA 510(k) Submission Details - K080555

510(k) Number K080555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2008
Decision Date June 03, 2008
Days to Decision 96 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 107d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 287
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