# K964647: North American Scientific (Nasi) 1-125 Radionuclide Brachytherapy Source

- Pathway: 510(k) (Traditional)
- Applicant: North American Scientific, Inc.
- Decided: Feb 10, 1997 after 82 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
No predicates in its family tree.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982226: Uromed Brachytheraphy Iodine-125 Sources (1999), 20 descendants of its own
- K021343: Isoseeds I-125 (2002), 18 descendants of its own
- K040339: Brachytherapy Strand Device (2004), 14 descendants of its own
- K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06 (2005), 9 descendants of its own
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge (2006), 7 descendants of its own

Source page: https://510kreport.com/device/K964647
Methodology: https://510kreport.com/methodology