# K973363: North American Scientific (Nasi)PD-103 Radionuclide Brachytherapy Source-Model MED3633

- Pathway: 510(k) (Traditional)
- Applicant: Ml Strategies, Inc.
- Decided: Jul 2, 1998 after 297 days
- Product code: IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The North American Scientific Corporation’s Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.

Source page: https://510kreport.com/device/K973363
Methodology: https://510kreport.com/methodology