Cleared Traditional

K131795 - NANOR AND EFFICAST/NANOR HYBRID THERMOP...

K131795 is the FDA 510(k) clearance for NANOR AND EFFICAST/NANOR HYBRID THERMOP... by Orfit Industries NV. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K131795 · Orfit Industries NV · Radiology device
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Sep 2013
Decision
100d
Days
Class 2
Risk

K131795 is an FDA 510(k) clearance for the NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS. 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 September 26, 2013 after a review of 100 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 K131795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date September 26, 2013
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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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