Kodak Ektascan Laser Printer, Model 100

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

510(k) Number

K863629 ↗

FDA Product Code

LMC

Device Class

Class II

Regulation

21 CFR Part 892.2040

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What is the Kodak Ektascan Laser Printer Model 100 used for?

  The Kodak Ektascan Laser Printer, Model 100 is a radiological imaging device that produces prints from radiological images. It is specifically designed for use in radiology departments to output images captured by radiological cameras.

• Is the Kodak Ektascan Laser Printer Model 100 a single-use device?

  The device data does not specify whether the Kodak Ektascan Laser Printer Model 100 is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

• What are the available models of the Kodak Ektascan Laser Printer?

  The device is supplied in various models as indicated by the multiple registration numbers provided in the device data. However, specific model details beyond the Model 100 are not included in the provided information.

• What is the regulatory status of the Kodak Ektascan Laser Printer Model 100?

  The Kodak Ektascan Laser Printer, Model 100 is a Class II medical device with FDA 510(k) clearance (K863629) and is manufactured by Eastman Kodak Company. It has been determined to be substantially equivalent to other legally marketed devices.