Cleared Traditional

K921341 - ACUSON V714OR TRANSDUCER

K921341 is the FDA 510(k) clearance for ACUSON V714OR TRANSDUCER by Acuson Corp.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K921341 · Acuson Corp. · Radiology device
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Nov 1992
Decision
252d
Days
Class 2
Risk

K921341 is an FDA 510(k) clearance for the ACUSON V714OR 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 November 27, 1992 after a review of 252 days - an extended review cycle.

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 Acuson Corp. devices

Submission Details

510(k) Number K921341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1992
Decision Date November 27, 1992
Days to Decision 252 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
145d slower than avg
Panel avg: 107d · This submission: 252d
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 K921341.
MODIFICATION OF ACUSON V510B TRANSDUCER
K933663 · Acuson Corp. · Jan 1994
ACUSON V714 TRANSDUCER
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UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
K925486 · Aloka Co., Ltd. · Feb 1993
SONICATH(TM) 3.5 F, 20 MHZ
K913890 · Boston Scientific Corp · Nov 1992
UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35
K922549 · Aloka Co., Ltd. · Sep 1992
CPA/3.5 MHZ PROBE
K911435 · Diasonics, Inc. · Sep 1992