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General X-Ray, Inc.

United StatesFDA applicant, unverified

Devices
14

What General X-Ray, Inc. makes

General X-Ray, Inc. manufactures a range of fixed and portable X-ray systems, including mobile and portable X-ray units, portable X-ray stands, and specialized units like the ATLAS-S X-ray system with a ketromat generator. Their portfolio includes both general-purpose portable X-ray units (e.g., GX-101, UCIS-510, GX-111) and dedicated mobile carriers for transport. Additional offerings include a 510 Carbinette X-ray unit and portable X-ray units with matrix S technology.

The company’s devices are classified under FDA’s Class I and Class II categories, with submissions recorded in the FDA’s 510(k) registry. These products are intended for radiographic imaging and are subject to U.S. regulatory requirements for medical X-ray equipment. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

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  • Atlas-S X-Ray System W/Ketromat Gen. Ref K800998

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

  • X-Ray Unit, Portable Gx-101 Aec Ref K781030

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

  • X-Ray Units, Gx-101, Ucis-510 And Gx-111 Ref K790451

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

  • Mobile Carrier Ref K781975

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

  • Portable X-Ray Unit Ref K781590

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

  • Mobile X-Ray Unit Ref K790511

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

  • Portable X-Ray Unit Ref K790512

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

  • 510 Carbinette X-Ray Unit Ref K790392

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

  • X-Ray Stand, Portable Ref K781676

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

  • Mobile X-Ray Unit Ref K781976

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

  • Portable X-Ray Unit Ref K790443

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

  • Portable X-Ray Unit, Matrix S Gx-101 Ref K790393

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

  • X-Ray Collimator Ref K781675

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

  • X-Ray System Ref K780963

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

Rows 1-14 of 14

Frequently asked questions

How many devices does General X-Ray, Inc. have in the registry?

The registry currently lists 14 devices for General X-Ray, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list General X-Ray, Inc.'s devices?

Among its 14 most recently registered devices, General X-Ray, Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do General X-Ray, Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for General X-Ray, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from General X-Ray, Inc. in the registry?

The most recently registered devices listed for General X-Ray, Inc. include ATLAS-S X-RAY SYSTEM W/KETROMAT GEN., X-RAY UNIT, PORTABLE GX-101 AEC, X-RAY UNITS, GX-101, UCIS-510 AND GX-111 and MOBILE CARRIER.

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