Cleared Abbreviated

K030162 - LAWRENCE CSERION, MODEL CS-1

K030162 is an FDA 510(k) clearance for LAWRENCE CSERION, manufactured by Isoray, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Abbreviated 510(k) pathway after a 71-day FDA review.

K030162 · Isoray, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K030162

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

KXK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 140
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K030162.
I-125 RAPID STRAND, MODEL 7000
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SEED LINK
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K023210 · Sourcetech Medical, LLC · Mar 2003
ALTON PT STEPPER
K024183 · Alton Design, LLC · Mar 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · Varian Medical Systems · Mar 2003
OPTIDOS
K010705 · Ptw-New York Corp. · Mar 2003