Isoray, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Isoray, Inc. makes
Isoray, Inc. manufactures radioactive sources and delivery systems for targeted radiation therapy, including liquid cesium-131 solutions for brachytherapy applications and preloaded cesium-131 strands designed for interstitial implantation. Their products are used in conjunction with specialized applicators like the GLIASITE RTS system for localized treatment of tumors.
These devices are classified as Class II under FDA regulations and require 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database. Isoray, Inc. is based in the United States.
Catalogue
Lawrence Cserion, Model Cs-1 Ref K030162
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isoray, Inc. have in the registry?
The registry currently lists 3 devices for Isoray, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isoray, Inc.'s devices?
Among its 3 most recently registered devices, Isoray, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Isoray, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Isoray, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isoray, Inc. in the registry?
The most recently registered devices listed for Isoray, Inc. include LAWRENCE CSERION, MODEL CS-1, CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS and CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE.