Mitsubishi Intl. Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Mitsubishi Intl. Corp. makes
Mitsubishi Intl. Corp. manufactures linear accelerators (LINACs) for radiation therapy, including the EXL-15DP, EXL-20DP, EXL-14, and EXL-22DP models, as well as X-ray radiation therapy systems. Their portfolio also includes multi-leaf collimators, which are precision devices used to shape radiation beams in cancer treatment. These systems are designed for high-energy photon and electron beam delivery in clinical settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they must comply with FDA requirements for radiation-emitting medical devices. No other regulatory registries or jurisdictions are specified.
Catalogue
Exl-15DP & 20-Dp Linac Ref K952108
Regimes: 510(k) Registry: 510(k)Multi Leaf Collimator Ref K961214
Regimes: 510(k) Registry: 510(k)Exl-14 Medical Linear Accelerator Ref K880200
Regimes: 510(k) Registry: 510(k)Exl-22DP X-Ray Radiation Therapy System Ref K873398
Regimes: 510(k) Registry: 510(k)Exl-12SP & 12DP Linac Ref K952314
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mitsubishi Intl. Corp. have in the registry?
The registry currently lists 5 devices for Mitsubishi Intl. Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitsubishi Intl. Corp.'s devices?
Among its 5 most recently registered devices, Mitsubishi Intl. Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Mitsubishi Intl. Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Mitsubishi Intl. Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mitsubishi Intl. Corp. in the registry?
The most recently registered devices listed for Mitsubishi Intl. Corp. include EXL-15DP & 20-DP LINAC, MULTI LEAF COLLIMATOR, EXL-14 MEDICAL LINEAR ACCELERATOR and EXL-22DP X-RAY RADIATION THERAPY SYSTEM.