Cleared Traditional

K942296 - V5M

K942296 is the FDA 510(k) clearance for V5M by Acuson Corp.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K942296 · Acuson Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
294d
Days
Class 2
Risk

K942296 is an FDA 510(k) clearance for the V5M. 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 2, 1995 after a review of 294 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 K942296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1994
Decision Date March 02, 1995
Days to Decision 294 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
187d slower than avg
Panel avg: 107d · This submission: 294d
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 K942296.
SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM
K945796 · Sharplan Lasers, Inc. · May 1995
OLYMPUS ULTRASONIC PROBES
K944610 · Olympus America, Inc. · Apr 1995
ACUSON MODEL 3001
K935595 · Acuson Corp. · Mar 1995
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