Cleared Special

MAGIS1 (K061713) - FDA 510(k) Clearance

Also marketed or referenced as:
MAGIS2

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

K061713 · Direx Systems Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
32d
Days
Class 2
Risk

K061713 is an FDA 510(k) clearance for the MAGIS1. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Direx Systems Corp. (Canton, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 32 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 Direx Systems Corp. devices

Submission Details

510(k) Number K061713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date July 21, 2006
Days to Decision 32 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
75d faster than avg
Panel avg: 107d · This submission: 32d
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 K061713.
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ONCOR EXPRESSION
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VISION
K042956 · Varian Medical Systems, Inc. · Mar 2005