Cleared Special

K012289 - MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) (FDA 510(k) Clearance)

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

K012289 · Elekta Oncology Systems, Ltd. · Radiology device
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Aug 2001
Decision
25d
Days
Class 2
Risk

K012289 is an FDA 510(k) clearance for the MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Elekta Oncology Systems, Ltd. (Norcross, US). The FDA issued a Cleared decision on August 14, 2001 after a review of 25 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 Elekta Oncology Systems, Ltd. devices

Submission Details

510(k) Number K012289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2001
Decision Date August 14, 2001
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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

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