Cleared Traditional

K111676 - APEX

K111676 is an FDA 510(k) clearance for APEX, manufactured by Elekta Limited. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K111676 · Elekta Limited · Radiology device
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Sep 2011
Decision
107d
Days
Class 2
Risk

K111676 is an FDA 510(k) clearance for the APEX. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Elekta Limited (West Sussex, GB). The FDA issued a Cleared decision on September 30, 2011 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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 Elekta Limited devices

FDA 510(k) Submission Details - K111676

510(k) Number K111676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2011
Decision Date September 30, 2011
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 14
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K111676.
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