Cleared Traditional

RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL (K963169) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 94
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K963169.
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
K970034 · Hewlett-Packard Co. · Mar 1997
PVK-720ST ENDOCAVITARY TRANSDUCER
K964865 · Toshiba America Medical Systems, In.C · Mar 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · Toshiba America Medical Systems, In.C · Mar 1997
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
K952892 · Olympus America, Inc. · Feb 1996
GE B510 TRANSDUCER
K951723 · GE Medical Systems · Nov 1995
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM
K944017 · Olympus America, Inc. · Jun 1995