Mitsubishi Heavy Industries, Ltd.
JapanFDA applicant, unverified
- Devices
- 3
What Mitsubishi Heavy Industries, Ltd. makes
Mitsubishi Heavy Industries, Ltd. manufactures linear accelerator systems, including the MHI-TM2000 series with VERO and Imavis configurations, designed for radiotherapy applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the US.
Catalogue
Mhi-TM2000 Linear Accelerator System Vero Imavis Ref K122450
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Mhi-TM2000 Linear Accelerator System Ref K072047
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mitsubishi Heavy Industries, Ltd. have in the registry?
The registry currently lists 3 devices for Mitsubishi Heavy Industries, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitsubishi Heavy Industries, Ltd.'s devices?
Among its 3 most recently registered devices, Mitsubishi Heavy Industries, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Mitsubishi Heavy Industries, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Mitsubishi Heavy Industries, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mitsubishi Heavy Industries, Ltd. in the registry?
The most recently registered devices listed for Mitsubishi Heavy Industries, Ltd. include MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS, MHI-TM2000 Linear Accelerator System, VERO, Imavis and MHI-TM2000 LINEAR ACCELERATOR SYSTEM.