Mitsubishi Electronics America, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Mitsubishi Electronics America, Inc. makes
The company manufactures linear accelerators (LINACs) for radiation therapy, including models like the EXL-12SP, 12DP, 15DP, and 20DP, which deliver precise external beam radiotherapy. It also produces dynamic wedges for dose shaping in radiation treatment plans and multileaf collimators, such as the 120 LEAF model, used to shape radiation fields during radiotherapy sessions.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
120 Leaf Multileaf Collimator Ref K973963
Regimes: 510(k) Registry: 510(k)Dynamic Wedge Ref K970564
Regimes: 510(k) Registry: 510(k)Exl-12SP, 12DP, 15DP, 20DP Linac Ref K970137
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mitsubishi Electronics America, Inc. have in the registry?
The registry currently lists 3 devices for Mitsubishi Electronics America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitsubishi Electronics America, Inc.'s devices?
Among its 3 most recently registered devices, Mitsubishi Electronics America, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Mitsubishi Electronics America, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Mitsubishi Electronics America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mitsubishi Electronics America, Inc. in the registry?
The most recently registered devices listed for Mitsubishi Electronics America, Inc. include 120 LEAF MULTILEAF COLLIMATOR, DYNAMIC WEDGE and EXL-12SP, 12DP, 15DP, 20DP LINAC.