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Tomo Therapy, Inc.

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Devices
1

What Tomo Therapy, Inc. makes

Tomo Therapy, Inc. manufactures the HI-ART System, a radiation therapy device designed for high-precision, intensity-modulated proton therapy. This system is used in the treatment of cancerous tumors, delivering targeted radiation doses to minimize exposure to surrounding healthy tissue.

The HI-ART System is classified as a Class II medical device in the U.S. and has undergone 510(k) clearance through the FDA. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Hi-Art System Ref K013673

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Tomo Therapy, Inc. have in the registry?

The registry currently lists 1 device for Tomo Therapy, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tomo Therapy, Inc.'s devices?

Among its 1 most recently registered device, Tomo Therapy, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Tomo Therapy, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Tomo Therapy, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Tomo Therapy, Inc. in the registry?

The most recently registered devices listed for Tomo Therapy, Inc. include HI-ART SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.