Cleared Traditional

K933663 - MODIFICATION OF ACUSON V510B TRANSDUCER

K933663 is the FDA 510(k) clearance for MODIFICATION OF ACUSON V510B TRANSDUCER by Acuson Corp.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K933663 · Acuson Corp. · Radiology device
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Jan 1994
Decision
177d
Days
Class 2
Risk

K933663 is an FDA 510(k) clearance for the MODIFICATION OF ACUSON V510B 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 January 21, 1994 after a review of 177 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 K933663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1993
Decision Date January 21, 1994
Days to Decision 177 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 107d · This submission: 177d
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 K933663.
ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
K921695 · Parker Laboratories, Inc. · Feb 1995
SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
K943637 · Aloka Co., Ltd. · Dec 1994
DIAGNOSTIC ULTRASOUND IMAGING CATHETER
K940108 · Boston Scientific Corp · Dec 1994
ACUSON V714 TRANSDUCER
K920882 · Acuson Corp. · Mar 1993
UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
K925486 · Aloka Co., Ltd. · Feb 1993
ACUSON V714OR TRANSDUCER
K921341 · Acuson Corp. · Nov 1992