# K030162: Lawrence Cserion, Model CS-1

- Pathway: 510(k) (Abbreviated)
- Applicant: Isoray, Inc.
- Decided: Mar 28, 2003 after 71 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: 1 generation back to K924261 (1993). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924261: Radioactive Cesium-131 Seeds/Sources, Best Industries (1993) Summary page 1.
- K010283: Theraseed (R) Palladium-103 Implant; Model 200, Theragenics Corp. (2001)

## Most influential descendants
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge (2006), 7 descendants of its own
- 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

## Indications for use
IsoRay, Inc. Lawrence CSERION seeds 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, The seeds 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.

Source page: https://510kreport.com/device/K030162
Methodology: https://510kreport.com/methodology