Kodak Digital Science Cardiac Viewer

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

510(k) Number

K974086 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What is the Kodak Digital Science Cardiac Viewer used for?

  The Kodak Digital Science Cardiac Viewer is intended for the display and review of cardiac images, supporting the visualization of digital cardiac data to aid clinical assessment in radiology settings.

• Is the Kodak Digital Science Cardiac Viewer sterile or non-sterile, and is it reusable?

  The device is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for multiple uses after appropriate cleaning and disinfection in accordance with institutional protocols.

• How was the Kodak Digital Science Cardiac Viewer authorized for marketing in the United States?

  The device received FDA 510(k) clearance under submission K974086 on January 20, 1998, based on a determination of substantial equivalence to a legally marketed predicate device.