Compact Laser Imager, Model CLI-100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K902347 ↗

FDA Product Code

LMC

Device Class

Class II

Regulation

21 CFR Part 892.2040

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 Eraser

  Class II

  FDA 510(k) K980809 Active Cleared 11 May 1998

• Lumiscan 50

  Class II

  FDA 510(k) K933129 Active Cleared 7 Oct 1993

• Di-2000

  Class II

  FDA 510(k) K980213 Active Cleared 17 Mar 1998

• Lumisys Lumiscan 20

  Class II

  FDA 510(k) K953964 Active Cleared 18 Sep 1995

• Digital Image Scanner, Model Dis-1000

  Class II

  FDA 510(k) K901423 Active Cleared 30 Apr 1990

• Lumisys Dicom Tooklit

  Class I

  FDA 510(k) K953371 Active Cleared 18 Oct 1995

• What is the Compact Laser Imager CLI-100 used for?

  The Compact Laser Imager CLI-100 is designed specifically for capturing high-resolution digital images of radiographic films and other medical imaging media. It employs laser scanning technology to digitize analog images, enabling seamless storage, transmission, and analysis within radiology departments and diagnostic imaging centers. This conversion streamlines workflows by eliminating the need for physical film handling while maintaining image fidelity for diagnostic purposes.

• Is the Compact Laser Imager CLI-100 reusable or single-use?

  The Compact Laser Imager CLI-100 is a reusable device. To ensure consistent performance and image quality, it requires proper calibration and maintenance as outlined in the manufacturer’s guidelines. Regular upkeep is essential to preserve functionality and accuracy over repeated use in clinical environments.

• What storage conditions are required for the Compact Laser Imager CLI-100?

  The Compact Laser Imager CLI-100 must be stored and handled according to the manufacturer’s specifications to maintain its functionality and ensure image fidelity. While specific storage conditions are not detailed in the provided data, it is critical to follow Lumisys, Inc.’s instructions to avoid environmental factors that could compromise the device’s performance, such as exposure to magnetic fields or extreme temperatures.

• Can the Compact Laser Imager CLI-100 be used in an MRI environment?

  No, the Compact Laser Imager CLI-100 is explicitly not MRI-safe. It must be used in non-magnetic environments to prevent interference with the device’s operation or potential safety risks. Always verify the surrounding equipment and environment before use to ensure compliance with safety protocols.

• What regulatory approval does the Compact Laser Imager CLI-100 hold?

  The Compact Laser Imager CLI-100 is authorized under FDA 510(k) clearance with the reference number K902347. It falls under the Radiology advisory committee (RA) and is classified as substantially equivalent (SESE) under FDA’s Class II regulatory category. This clearance ensures it meets stringent performance and safety standards for radiological imaging devices, including compliance with guidelines from the Radiology advisory committee.