# K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge

- Pathway: 510(k) (Special)
- Applicant: Isoray, Inc.
- Decided: Nov 9, 2006 after 86 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801748 (1980). 23 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030162: Lawrence Cserion, Model CS-1, Isoray, Inc. (2003) Summary page 1.
- K011155: Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S, Ibt, Inc. (2001)
- K030594: I-125 Rapid Strand, Model 7000, Amersham Health (2003) Summary page 1.
- K043336: Optistrand, Model 1032S, Ibt SA (2005) Summary page 1.
- K040339: Brachytherapy Strand Device, Bebig Isotopen-Und Medizintechnik GmbH (2004) Summary page 1.
- K041702: EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.), Ibt SA (2004)
- K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06, Theragenics Corp. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K060636: Palladium-103 Seed Implant Kits -Multiple, C.R. Bard, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (2009), 4 descendants of its own
- K180515: GammaTile (2018), 3 descendants of its own
- K190296: GammaTile (2019), 2 descendants of its own
- K190839: GammaTile (2020), 1 descendant of its own
- K092458: Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18 Guage Needles, Model PL-2 (2009), 1 descendant of its own

## Indications for use
IsoRay Medical, Inc. Cesium-131 Implant Devices are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. These devices may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors. The Cesium-131 Implant Devices have the same indications for use as the original device, the IsoRay Medical Inc. Cs-131 Brachytherapy Seed, Model CS-I

Source page: https://510kreport.com/device/K062384
Methodology: https://510kreport.com/methodology