Cleared Traditional

K963169 - RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL

K963169 is an FDA 510(k) clearance for RAPID-AID THERAPEUTIC/SCANNING ULTRASOU..., manufactured by Rapid-Aid Ltd./Ltee. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963169 · Rapid-Aid Ltd./Ltee · Radiology device
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Nov 1996
Decision
90d
Days
Class 2
Risk

K963169 is an FDA 510(k) clearance for the RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Rapid-Aid Ltd./Ltee (Mississuaga,Ontario, CA). The FDA issued a Cleared decision on November 12, 1996 after a review of 90 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 Rapid-Aid Ltd./Ltee devices

FDA 510(k) Submission Details - K963169

510(k) Number K963169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date November 12, 1996
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 K963169.
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