Cleared Traditional

K052383 - INNOCURE IMRT FILTER (COMPENSATORS)

K052383 is an FDA 510(k) clearance for INNOCURE IMRT FILTER (COMPENSATORS), manufactured by Innocure, LLC. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K052383 · Innocure, LLC · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
211d
Days
Class 2
Risk

K052383 is an FDA 510(k) clearance for the INNOCURE IMRT FILTER (COMPENSATORS). Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Innocure, LLC (Tempe, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 211 days - an extended review cycle.

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 Innocure, LLC devices

FDA 510(k) Submission Details - K052383

510(k) Number K052383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2005
Decision Date March 29, 2006
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
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 23
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K052383.
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K000137 · Computerized Medical Systems, Inc. · Apr 2000