Cleared Traditional

K961002 - DIASONICS ITNRAOPERATIVE PROBES

K961002 is an FDA 510(k) clearance for DIASONICS ITNRAOPERATIVE PROBES, manufactured by Diasonics Ultrasound. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K961002 · Diasonics Ultrasound · Radiology device
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Jan 1997
Decision
316d
Days
Class 2
Risk

K961002 is an FDA 510(k) clearance for the DIASONICS ITNRAOPERATIVE PROBES. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Diasonics Ultrasound (Santa Clara, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Diasonics Ultrasound devices

FDA 510(k) Submission Details - K961002

510(k) Number K961002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1996
Decision Date January 22, 1997
Days to Decision 316 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 107d · This submission: 316d
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 304
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K961002.
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
K961974 · Pentax Precision Instrument Corp. · Feb 1997
SHEATHES (NON-LATEX)
K963831 · Medical Resources · Feb 1997
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
K963302 · Tayman Medical, Inc. · Feb 1997
ULTRAMIX
K962093 · Sonotech, Inc. · Dec 1996
ECOLOTION TRANSMISSION AND MASSAGE LOTION
K962840 · Eco-Med Pharmaceuticals, Inc. · Dec 1996
RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL
K963169 · Rapid-Aid Ltd./Ltee · Nov 1996