Cleared Traditional

K964865 - PVK-720ST ENDOCAVITARY TRANSDUCER

K964865 is the FDA 510(k) clearance for PVK-720ST ENDOCAVITARY TRANSDUCER by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K964865 · Toshiba America Medical Systems, In.C · Radiology device
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Mar 1997
Decision
96d
Days
Class 2
Risk

K964865 is an FDA 510(k) clearance for the PVK-720ST ENDOCAVITARY TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 96 days - within the typical 510(k) review window.

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 America Medical Systems, In.C devices

Submission Details

510(k) Number K964865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date March 10, 1997
Days to Decision 96 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
11d faster than avg
Panel avg: 107d · This submission: 96d
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 188
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K964865.
BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
K971700 · Biosound, Inc. · Jul 1997
ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER
K964549 · Aloka Co., Ltd. · Jun 1997
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
K970034 · Hewlett-Packard Co. · Mar 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · Toshiba America Medical Systems, In.C · Mar 1997
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
K961974 · Pentax Precision Instrument Corp. · Feb 1997
INTRACAVITY TRANSDUCERS
K953716 · Biosound, Inc. · Apr 1996