Cleared Traditional

K921341 - ACUSON V714OR TRANSDUCER

K921341 is an FDA 510(k) clearance for ACUSON V714OR TRANSDUCER, manufactured by Acuson Corp.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K921341

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.

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 336
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K921341.
CARDIOMETRICS FLOWIRE & FLOMAP
K932536 · Cardio Metrics, Inc. · Sep 1993
ACUSON V714 TRANSDUCER
K920882 · Acuson Corp. · Mar 1993
UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
K925486 · Aloka Co., Ltd. · Feb 1993
INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE
K915696 · Interspec, Inc. · Nov 1992
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