Cleared Special

K062384 - CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE

K062384 is an FDA 510(k) clearance for CESIUM-131 STRAND, manufactured by Isoray, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Special 510(k) pathway after a 86-day FDA review.

K062384 · Isoray, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
86d
Days
Class 2
Risk

K062384 is an FDA 510(k) clearance for the CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE. 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 November 9, 2006 after a review of 86 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062384

510(k) Number K062384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2006
Decision Date November 09, 2006
Days to Decision 86 days
Submission Type Special
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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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
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