Cleared Traditional

K113276 - CATALYST

K113276 is the FDA 510(k) clearance for CATALYST by C-Rad Positioning AB. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K113276 · C-Rad Positioning AB · Radiology device
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Feb 2012
Decision
112d
Days
Class 2
Risk

K113276 is an FDA 510(k) clearance for the CATALYST. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by C-Rad Positioning AB (Uppsala, SE). The FDA issued a Cleared decision on February 27, 2012 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all C-Rad Positioning AB devices

Submission Details

510(k) Number K113276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date February 27, 2012
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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