Cleared Traditional

K200435 - Catalyst+

K200435 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 73-day FDA review.

K200435 · C-Rad Positioning AB · Radiology device
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May 2020
Decision
73d
Days
Class 2
Risk

K200435 is an FDA 510(k) clearance for the Catalyst+, Catalyst+ HD. 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 May 7, 2020 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C-Rad Positioning AB devices

Submission Details

510(k) Number K200435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2020
Decision Date May 07, 2020
Days to Decision 73 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 107d · This submission: 73d
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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