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Viztek, Inc.

Also registered as Viztek, LLC

United StatesFDA 510(k) applicant, unverified

Devices
11

What Viztek, Inc. makes

Viztek, Inc. manufactures picture archiving and communication systems (PACS) for radiology, including the ONYX-RAD Telemedicine PACS for remote imaging access, the OPAL-RAD for radiology workflow integration, and wireless solutions like VIZTEK WL. Their digital radiography systems—such as the VIZION DR and VIZTEK DR (models DR1000, DR3000, DR4000)—provide direct radiography imaging for diagnostic use.

The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory compliance. Viztek, Inc. is headquartered in the United States.

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

Catalogue11

Newest first, rows 1-11 of 11

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  • ViZion DR + Wireless Ref K152279

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

  • ViZion DR + Wireless Ref K160810

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

  • Onyx-Rad Telemedicine Pacs Ref K003607

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

  • Vizion + Dr Ref K123644

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

  • Vizion Dr Ref K112661

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

  • Opal-Rad Ref K063337

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

  • Vizion Ultra Ref K133139

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

  • Exa Ref K142919

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

  • Viztek Dr, Models: DR1000, DR3000, DR4000 Ref K082604

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

  • Vizion Dr Ref K102123

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

  • Viztek Wl Ref K091752

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

Rows 1-11 of 11

Frequently asked questions

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

The registry currently lists 11 devices for Viztek, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Viztek, Inc.'s devices?

Among its 11 most recently registered devices, Viztek, Inc. has devices listed in FDA 510(k) (11 devices).

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

Among its 11 most recently registered devices, the classes recorded for Viztek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Viztek, Inc. include ViZion DR + Wireless, ONYX-RAD TELEMEDICINE PACS, VIZION + DR and VIZION DR.

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