# K103319: I-SEED

- Pathway: 510(k) (Abbreviated)
- Applicant: Theragenics Corp.
- Decided: Jan 3, 2011 after 52 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: 3 generations back to K801748 (1980). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021343: Isoseeds I-125, Bebig Isotopen-Und Medizintechnik GmbH (2002) Summary page 1.
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.

## Indications for use
The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual, following, external beam or excision of primary tumor.

Source page: https://510kreport.com/device/K103319
Methodology: https://510kreport.com/methodology