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Lumisys, Inc.

United StatesFDA applicant, unverified

Devices
7

What Lumisys, Inc. makes

Lumisys, Inc. makes phosphor plate digitizers, erasers, and digital image scanners, including models such as the Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 Eraser, Lumiscan 50, DI-2000, Lumiscan 20, DIS-1000, and CLI-100. The company also produces the Lumisys DICOM Toolkit for digital imaging workflows.

These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Lumisys, Inc. is based in the United States.

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

Catalogue7

Newest first, rows 1-7 of 7

  • Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 Eraser Ref K980809

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Lumiscan 50 Ref K933129

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Di-2000 Ref K980213

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Lumisys, Lumiscan 20 Ref K953964

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Digital Image Scanner, Model Dis-1000 Ref K901423

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Compact Laser Imager, Model Cli-100 Ref K902347

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Lumisys Dicom Tooklit Ref K953371

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

Frequently asked questions

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

The registry currently lists 7 devices for Lumisys, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lumisys, Inc.'s devices?

Among its 7 most recently registered devices, Lumisys, Inc. has devices listed in FDA 510(k) (7 devices).

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

Among its 7 most recently registered devices, the classes recorded for Lumisys, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Lumisys, Inc. include LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER, LUMISCAN 50, DI-2000 and LUMISYS, LUMISCAN 20.

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