Cleared Traditional

K952913 - APPLICATORS FOR VARIAN VARISOURCE REMOT...

K952913 is the FDA 510(k) clearance for APPLICATORS FOR VARIAN VARISOURCE REMOT... by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K952913 · Varian Assoc., Inc. · Radiology device
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Nov 1995
Decision
149d
Days
Class 2
Risk

K952913 is an FDA 510(k) clearance for the APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K952913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date November 22, 1995
Days to Decision 149 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
42d slower than avg
Panel avg: 107d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 107
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K952913.
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K954467 · Varian Assoc., Inc. · Mar 1996
HIGH DOSE RATE AFTERLOADER
K945383 · Varian Assoc., Inc. · Feb 1995
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K923738 · Cook, Inc. · Apr 1993
GAMMAMED IRIDIUM-192 SOURCE
K894381 · Mick Radio-Nuclear Instruments, Inc. · Nov 1989