Theta Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Theta Systems, Inc. makes
Theta Systems, Inc. manufactures integral build-up photon diodes, such as the ISORAD™ series, which are used for accurate radiation dose measurement in medical imaging. The company also produces patient dose monitors, designed to track and assess radiation exposure during procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. Theta Systems, Inc. is based in the United States.
Catalogue
Isorad(Tm) Integral Buildup Photon Diodes Ref K912250
Regimes: 510(k) Registry: 510(k)Patient Dose Monitor Ref K912249
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Theta Systems, Inc. have in the registry?
The registry currently lists 2 devices for Theta Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Theta Systems, Inc.'s devices?
Among its 2 most recently registered devices, Theta Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Theta Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Theta Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Theta Systems, Inc. in the registry?
The most recently registered devices listed for Theta Systems, Inc. include ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES and PATIENT DOSE MONITOR.