# K982421: Imagyn 125 I Seed, Model IS 125

- Pathway: 510(k) (Special)
- Applicant: International Isotopes, Inc.
- Decided: Jul 31, 1998 after 18 days
- Product code: IWG (Seed, Isotope, 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
Longest line of descent: 1 generation back to K914281 (1991). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K990193: Iodine Brachytherapy Seeds, Model 3000 (1999), 4 descendants of its own
- K994317: I-Plant, Model 3500 (2000), 2 descendants of its own
- K090366: Spec Model M-31 (2009), 1 descendant of its own
- K141038: Ant Model 1 (2014), 0 descendants of its own
- K023242: I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-Sterile (2002), 0 descendants of its own

## Indications for use
Imagyn®I Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can to 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/K982421
Methodology: https://510kreport.com/methodology