# K972271: North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a

- Pathway: 510(k) (Traditional)
- Applicant: Ml Strategies, Inc.
- Decided: Oct 28, 1997 after 132 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.
29 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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

## Indications for use
The North American Scientific Corporation’s I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.

Source page: https://510kreport.com/device/K972271
Methodology: https://510kreport.com/methodology