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Infinitt Co., Ltd.

Also registered as Infinitt Company

Country not established

Devices
13

What Infinitt Co., Ltd. makes

Infinitt Co., Ltd. makes medical imaging and information systems, including PACS (Picture Archiving and Communication Systems) for cardiology, orthopedics, dental, and general radiology, as well as advanced visualization and fusion tools such as XELIS Cardiac, XELIS Dental, XELIS 3D, and XELIS Fusion. The company also produces gateway and connectivity solutions like the REFORMAT Gateway and lightweight viewing clients such as INFINITT ULite.

All listed devices are classified as Class II medical devices and are registered in the FDA’s 510(k) premarket notification database. The company is based in the United States.

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

Catalogue13

Newest first, rows 1-13 of 13

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  • Rapidiacolon Ref K041761

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

  • Infinitt Xelis Ref K082990

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

  • Infinitt G3 Pacs Ref K052545

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

  • Starpacs Dental Ref K051715

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

  • Infintt Co., Ltd. Starpacs System Ref K031013

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

  • Xelis Cardiac Ref K111660

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

  • Reformat Gateway Ref K052284

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

  • Xelis Fusion Ref K111613

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

  • Xelis Dental Ref K102684

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

  • Xelis 3D Ref K103130

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

  • Infinitt Cardiology Pacs Ref K082706

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

  • Starpacs Orthopedics System Ref K041500

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

  • INFINITT ULite Ref K163290

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

Rows 1-13 of 13

Frequently asked questions

How many devices does Infinitt Co., Ltd. have in the registry?

The registry currently lists 13 devices for Infinitt Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Infinitt Co., Ltd.'s devices?

Among its 13 most recently registered devices, Infinitt Co., Ltd. has devices listed in FDA 510(k) (13 devices).

What risk classes do Infinitt Co., Ltd.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Infinitt Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Infinitt Co., Ltd. in the registry?

The most recently registered devices listed for Infinitt Co., Ltd. include RAPIDIACOLON, INFINITT XELIS, INFINITT G3 PACS and STARPACS DENTAL.

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