Cleared Abbreviated

LIAC (K110840) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K110840 · Sordina S.P.A. · Radiology device
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Apr 2012
Decision
389d
Days
Class 2
Risk

K110840 is an FDA 510(k) clearance for the LIAC. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Sordina S.P.A. (Ormond Beach, US). The FDA issued a Cleared decision on April 17, 2012 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sordina S.P.A. devices

Submission Details

510(k) Number K110840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2011
Decision Date April 17, 2012
Days to Decision 389 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 107d · This submission: 389d
Pathway characteristics
Standards-based clearance path.

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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