Cleared Special

ON-BOARD IMAGER DEVICE (K042720) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042720 · Varian Medical Systems · Radiology device
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Oct 2004
Decision
28d
Days
Class 2
Risk

K042720 is an FDA 510(k) clearance for the ON-BOARD IMAGER DEVICE. 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 October 29, 2004 after a review of 28 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

Submission Details

510(k) Number K042720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date October 29, 2004
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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

All 204
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K042720.
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
K060633 · Siemens Medical Solutions USA, Inc. · May 2006
ONCOR EXPRESSION
K060226 · Siemens Medical Solutions USA, Inc. · Mar 2006
VISION
K042956 · Varian Medical Systems, Inc. · Mar 2005
MODIFICATION TO: ON-BOARD IMAGER DEVICE
K041519 · Varian Medical Systems, Inc. · Aug 2004
ON-BOARD IMAGER DEVICE
K040192 · Varian Medical Systems, Inc. · Feb 2004
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K033343 · Varian Medical Systems, Inc. · Dec 2003