International Isotopes, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What International Isotopes, Inc. makes
International Isotopes, Inc. manufactures radioactive seed implants for brachytherapy, including iodine-125 (I-125) seeds designed for targeted radiation treatment in medical procedures. These devices are used primarily in oncology for localized tumor control, such as prostate cancer therapy. The portfolio includes specific models like the IMAGYN I-125 seed and the I3RAD I-125 brachytherapy seed, which are engineered for precise internal radiation delivery.
The company’s devices fall under FDA Class II regulatory classification, requiring premarket notification (510(k)) clearance before commercial distribution in the United States. These products are listed in the FDA’s 510(k) database, reflecting their authorized status for interventional radiation applications. The manufacturer operates from the United States, adhering to domestic regulatory requirements for medical radiation sources.
Catalogue
Imagyn 125 I Seed, Model Is 125 Ref K982421
Regimes: 510(k) Registry: 510(k)I3RAD 125 I Brachytherapy Seed, Model I125-0401 Ref K992963
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does International Isotopes, Inc. have in the registry?
The registry currently lists 2 devices for International Isotopes, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list International Isotopes, Inc.'s devices?
Among its 2 most recently registered devices, International Isotopes, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do International Isotopes, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for International Isotopes, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from International Isotopes, Inc. in the registry?
The most recently registered devices listed for International Isotopes, Inc. include IMAGYN 125 I SEED, MODEL IS 125 and I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401.