North American Scientific, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What North American Scientific, Inc. makes
North American Scientific, Inc. manufactures brachytherapy devices, including implantation kits (SURTRAK and NSTRAND) for internal radiation therapy, an adjustable multi-cathéter source applicator for precise radiation delivery, and radionuclide sources (NASI 1-125) used in brachytherapy procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, reflecting their authorised status for interventional radiation applications in the US.
Catalogue
Surtrak Implantation Kit Ref K060679
Regimes: 510(k) Registry: 510(k)Adjustable Multi-Catheter Source Applictor Ref K062241
Regimes: 510(k) Registry: 510(k)Nstrand Implantation Kit Ref K052024
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does North American Scientific, Inc. have in the registry?
The registry currently lists 4 devices for North American Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list North American Scientific, Inc.'s devices?
Among its 4 most recently registered devices, North American Scientific, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do North American Scientific, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for North American Scientific, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from North American Scientific, Inc. in the registry?
The most recently registered devices listed for North American Scientific, Inc. include SURTRAK IMPLANTATION KIT, ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR, NSTRAND IMPLANTATION KIT and NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE.