Cleared Traditional

K162355 - Raycast MammoRx Carbon Fibre Breast Board

K162355 is the FDA 510(k) clearance for Raycast MammoRx Carbon Fibre Breast Board by Orfit Industries NV. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K162355 · Orfit Industries NV · Radiology device
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Nov 2016
Decision
91d
Days
Class 2
Risk

K162355 is an FDA 510(k) clearance for the Raycast MammoRx Carbon Fibre Breast Board. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Orfit Industries NV (Wijnegem, BE). The FDA issued a Cleared decision on November 22, 2016 after a review of 91 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 Orfit Industries NV devices

Submission Details

510(k) Number K162355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date November 22, 2016
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
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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