Cleared Traditional

K953819 - DIAGNOSTIC ULTRASOUND TRANDUCER

K953819 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND TRANDUCER, manufactured by Biosound, Inc.. The device is a Class 2 Radiology device width product code ITX cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K953819 · Biosound, Inc. · Radiology device
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Mar 1996
Decision
199d
Days
Class 2
Risk

K953819 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND TRANDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 199 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 Biosound, Inc. devices

Submission Details

510(k) Number K953819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date March 01, 1996
Days to Decision 199 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
92d slower than avg
Panel avg: 107d · This submission: 199d
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 K953819.
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
K961974 · Pentax Precision Instrument Corp. · Feb 1997
INTRACAVITY TRANSDUCERS
K953716 · Biosound, Inc. · Apr 1996
DIAGNOSTIC ULTRASOUND TRANSDUCER
K953759 · Biosound, Inc. · Mar 1996
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
K952892 · Olympus America, Inc. · Feb 1996
ULTRASOUND PROBE BIOPSY ACCESSORIES
K955458 · Biosound, Inc. · Feb 1996
TEE PROBE
K953579 · Biosound, Inc. · Feb 1996