# K991526: Isostar I-125 Interstitial Seed, Model IS-12501

- Pathway: 510(k) (Special)
- Applicant: Imagyn Medical Technologies, Inc.
- Decided: Jun 17, 1999 after 45 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: 2 generations back to K914281 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982421: Imagyn 125 I Seed, Model IS 125, International Isotopes, Inc. (1998) Summary page 1.
- K914825: 1-125 Endoseed, Endo Technic Corp. (1992) Summary page 1.
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.
- K972271: North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a, Ml Strategies, Inc. (1997) Summary page 1.

## Indications for use
Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

Source page: https://510kreport.com/device/K991526
Methodology: https://510kreport.com/methodology