Cleared Traditional

K863364 - DIAGNOSTIC ULTRASONIC TRANSDUCER

K863364 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASONIC TRANSDUCER, manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K863364 · Toshiba Medical Systems · Radiology device
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Feb 1987
Decision
178d
Days
Class 2
Risk

K863364 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASONIC TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on February 27, 1987 after a review of 178 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 Toshiba Medical Systems devices

FDA 510(k) Submission Details - K863364

510(k) Number K863364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1986
Decision Date February 27, 1987
Days to Decision 178 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 107d · This submission: 178d
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 204
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K863364.
DIASONICS SPA 3.5 MHZ, 30MM PROBE
K864812 · Diasonics, Inc. · Mar 1987
SERIES 620 RECTAL PROBE COVER
K864222 · General Electric Co. · Mar 1987
KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM
K862686 · Kontron Instruments, Inc. · Feb 1987
INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER
K855247 · Codman & Shurtleff, Inc. · Feb 1987
RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE
K863700 · General Electric Co. · Feb 1987
280SL IMAGING SYSTEM SMALL PARTS PROBES
K864135 · Ge Medical Systems Information Technologies · Jan 1987