Cleared Traditional

K926449 - VARIAN MULTILEAF COLLIMATOR

K926449 is the FDA 510(k) clearance for VARIAN MULTILEAF COLLIMATOR by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 862-day FDA review.

K926449 · Varian Assoc., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
862d
Days
Class 2
Risk

K926449 is an FDA 510(k) clearance for the VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 862 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Varian Assoc., Inc. devices

Submission Details

510(k) Number K926449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1992
Decision Date May 05, 1995
Days to Decision 862 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
755d slower than avg
Panel avg: 107d · This submission: 862d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

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