Cleared Traditional

K112286 - NOVAC 11

K112286 is an FDA 510(k) clearance for NOVAC 11, manufactured by New Radiant Technology S.P.A.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K112286 · New Radiant Technology S.P.A. · Radiology device
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Apr 2012
Decision
254d
Days
Class 2
Risk

K112286 is an FDA 510(k) clearance for the NOVAC 11. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by New Radiant Technology S.P.A. (North Reading, US). The FDA issued a Cleared decision on April 19, 2012 after a review of 254 days - an extended review 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: 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 New Radiant Technology S.P.A. devices

FDA 510(k) Submission Details - K112286

510(k) Number K112286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2011
Decision Date April 19, 2012
Days to Decision 254 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
147d slower than avg
Panel avg: 107d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

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

All 370
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