Cleared Traditional

K920882 - ACUSON V714 TRANSDUCER

K920882 is the FDA 510(k) clearance for ACUSON V714 TRANSDUCER by Acuson Corp.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K920882 · Acuson Corp. · Radiology device
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Mar 1993
Decision
394d
Days
Class 2
Risk

K920882 is an FDA 510(k) clearance for the ACUSON V714 TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on March 26, 1993 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Acuson Corp. devices

Submission Details

510(k) Number K920882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1992
Decision Date March 26, 1993
Days to Decision 394 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
287d slower than avg
Panel avg: 107d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 202
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K920882.
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