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Xre Corp.

United StatesFDA 510(k) applicant, unverified

Devices
20

What Xre Corp. makes

Xre Corp. manufactures radiographic imaging accessories and systems, including collimators, diagnostic catheters (e.g., UNICATH EP and UNICATH A), procedural tables (e.g., RADIAL TRAVEL SPEC.), and specialized imaging systems like the OMNI PLANE SYSTEM and QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM. Their portfolio also includes bi-plane imaging systems (e.g., UNICATH SP BI-PLANE), fluoroscopic zoom systems (e.g., FULL FRAME ZOOM SYSTEM), and quality assurance tools (e.g., CINEMAC QAS). The company produces both standalone components and integrated solutions for interventional and diagnostic radiology procedures.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. Their products are intended for use in the United States, where they must comply with U.S. medical device regulations. No additional international registries or classifications are specified.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

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  • Xre Collimator Ref K960998

    Class II
    Active 510(k) 510(k) II

  • Unicath Ep. Ref K913685

    Class II
    Active 510(k) 510(k) II

  • Poly Diagnost Cdx Ref K923654

    Class II
    Active 510(k) 510(k) II

  • Unicath Lab Ref K875184

    Class II
    Active 510(k) 510(k) II

  • Radial Travel Spec. Procedures Table Ref K761339

    Class II
    Active 510(k) 510(k) II

  • Unicath Sp Bi-Plane (Model M269 & M289) Ref K973744

    Class II
    Active 510(k) 510(k) II

  • Omni Plane System Ref K854085

    Class II
    Active 510(k) 510(k) II

  • Bi-N Ref K924828

    Class II
    Active 510(k) 510(k) II

  • Cinemac Qas Ref K936002

    Class II
    Active 510(k) 510(k) II

  • Unicath A Ref K892849

    Class II
    Active 510(k) 510(k) II

  • Full Frame Zoom System Ref K961193

    Class II
    Active 510(k) 510(k) II

  • Quantix Cardiac Angiographic System Ref K850455

    Class II
    Active 510(k) 510(k) II

  • Trauma Table Ii Ref K874114

    Class II
    Active 510(k) 510(k) II

  • Dental Cassette Holders Ref K837515

    Not classified
    Active 510(k) 510(k) —

  • Unicath Llu Angiographic System Ref K945449

    Class II
    Active 510(k) 510(k) II

  • Omni Diagnost Ref K874113

    Class II
    Active 510(k) 510(k) II

  • Angiographic Or Fluoroscopic X-Ray System Ref K912416

    Class II
    Active 510(k) 510(k) II

  • Dvfx, Model M256 Ref K933460

    Class II
    Active 510(k) 510(k) II

  • Trauma Table Ref K853535

    Class I
    Active 510(k) 510(k) I

  • Trauma Stand Ref K852952

    Class I
    Active 510(k) 510(k) I

Rows 1-20 of 20

Frequently asked questions

How many devices does Xre Corp. have in the registry?

The registry currently lists 20 devices for Xre Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Xre Corp.'s devices?

Among its 20 most recently registered devices, Xre Corp. has devices listed in FDA 510(k) (20 devices).

What risk classes do Xre Corp.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Xre Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Xre Corp. in the registry?

The most recently registered devices listed for Xre Corp. include XRE COLLIMATOR, UNICATH EP., POLY DIAGNOST CDX and UNICATH LAB.

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