Cleared Traditional

K100267 - FLEXIMARC, MODEL CM-0.9-2-10-GG-L (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100267 · Cortex Manufacturing, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2010
Decision
26d
Days
Class 2
Risk

K100267 is an FDA 510(k) clearance for the FLEXIMARC, MODEL CM-0.9-2-10-GG-L. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Cortex Manufacturing, Inc. (Lake Stevens, US). The FDA issued a Cleared decision on February 24, 2010 after a review of 26 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 Cortex Manufacturing, Inc. devices

Submission Details

510(k) Number K100267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2010
Decision Date February 24, 2010
Days to Decision 26 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
81d faster than avg
Panel avg: 107d · This submission: 26d
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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