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Tg Group, Inc.

CanadaFDA applicant, unverified

Devices
1

What Tg Group, Inc. makes

Tg Group, Inc. manufactures the IMAGE-X SYSTEM, a medical imaging device classified as a Class II product.

The IMAGE-X SYSTEM is regulated under the FDA 510(k) pathway and is listed in the FDA 510(k) registry; Tg Group, Inc. is based in the United States.

AI-generated from registry data, 23 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Image-X System Ref K012355

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

Frequently asked questions

How many devices does Tg Group, Inc. have in the registry?

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

Which registries list Tg Group, Inc.'s devices?

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

What risk classes do Tg Group, Inc.'s devices fall under?

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

What are the newest devices from Tg Group, Inc. in the registry?

The most recently registered devices listed for Tg Group, Inc. include IMAGE-X SYSTEM.

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