Cleared Special

ON-BOARD IMAGER DEVICE (K040192) - FDA 510(k) Clearance

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

K040192 · Varian Medical Systems, Inc. · Radiology device
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Feb 2004
Decision
30d
Days
Class 2
Risk

K040192 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, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 27, 2004 after a review of 30 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, Inc. devices

Submission Details

510(k) Number K040192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2004
Decision Date February 27, 2004
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 203
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K040192.
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
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K033343 · Varian Medical Systems, Inc. · Dec 2003
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
K031764 · Siemens Medical Solutions USA, Inc. · Sep 2003
ECLIPSE 6.5
K010975 · Varian Medical Systems, Inc. · May 2001