Cleared Special

K071992 - HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)

K071992 is an FDA 510(k) clearance for HIGH-DEFINITION 120 MULTILEAF COLLIMATO..., manufactured by Varian Medical Systems. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 26-day FDA review.

K071992 · Varian Medical Systems · Radiology device
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Aug 2007
Decision
26d
Days
Class 2
Risk

K071992 is an FDA 510(k) clearance for the HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Varian Medical Systems devices

FDA 510(k) Submission Details - K071992

510(k) Number K071992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2007
Decision Date August 15, 2007
Days to Decision 26 days
Submission Type Special
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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

IYE Device Classification - Class 2, Special Controls

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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