Cleared Traditional

DOSE VERIFICATION SYSTEM (K052118) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052118 · Sicel Technologies, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2006
Decision
242d
Days
Class 2
Risk

K052118 is an FDA 510(k) clearance for the DOSE VERIFICATION SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Sicel Technologies, Inc. (Morrisville, US). The FDA issued a Cleared decision on April 3, 2006 after a review of 242 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 Sicel Technologies, Inc. devices

Submission Details

510(k) Number K052118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2005
Decision Date April 03, 2006
Days to Decision 242 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
135d slower than avg
Panel avg: 107d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHN System, Radiation Therapy, Charged-particle, 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 - LHN System, Radiation Therapy, Charged-particle, Medical

All 27
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