Cleared Abbreviated

K030162 - LAWRENCE CSERION, MODEL CS-1 (FDA 510(k) Clearance)

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

K030162 · Isoray, Inc. · Radiology device
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Mar 2003
Decision
71d
Days
Class 2
Risk

K030162 is an FDA 510(k) clearance for the LAWRENCE CSERION, MODEL CS-1. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoray, Inc. (Richland, US). The FDA issued a Cleared decision on March 28, 2003 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Isoray, Inc. devices

Submission Details

510(k) Number K030162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2003
Decision Date March 28, 2003
Days to Decision 71 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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.