# K984235: Intersource 125, Model 1251L

- Pathway: 510(k) (Traditional)
- Applicant: International Brachytherapy, Inc.
- Decided: Jun 9, 1999 after 196 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 K914281 (1991). 1 ancestor in all.
9 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)
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.

## Most influential descendants
- K041702: EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.) (2004), 8 descendants of its own
- 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

## Indications for use
InterSource® implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSource® implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.

Source page: https://510kreport.com/device/K984235
Methodology: https://510kreport.com/methodology