Kodak X-Omat Processor Model ME-3

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K860666 ↗

FDA Product Code

IXW

Device Class

Class II

Regulation

21 CFR Part 892.1900

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What types of facilities or departments would benefit most from using the Kodak X-Omat Processor Model ME-3, and why?

  The Kodak X-Omat Processor Model ME-3 is specifically designed for radiology settings, where it automates the development and processing of radiographic film to produce diagnostic-quality images. Its precise temperature and timing controls ensure consistent results, making it ideal for hospitals, clinics, or imaging centers that rely on radiographic film for diagnostic purposes. The reusable nature of the system also supports long-term use in environments where frequent film processing is required.

• How is the Kodak X-Omat Processor Model ME-3 different from manual film processing methods, and what advantages does it offer?

  Unlike manual processing, the Kodak X-Omat Processor Model ME-3 automates the entire chemical processing sequence for radiographic film, eliminating human variability in timing and temperature. This automation ensures consistent, high-quality diagnostic images every time, reducing the risk of errors associated with manual handling. The processor’s precise controls also streamline workflows in radiology departments, saving time and labor while maintaining reliability.

• Is the Kodak X-Omat Processor Model ME-3 a single-use or reusable device, and what maintenance is required to keep it functioning properly?

  The Kodak X-Omat Processor Model ME-3 is designed as a reusable system, meaning it is built to be used repeatedly over time with proper care. To maintain performance, it requires regular maintenance and calibration, as outlined in the manufacturer’s guidelines. This includes monitoring chemical levels, cleaning components, and ensuring temperature and timing controls remain accurate, all of which are critical for producing consistent radiographic images.

• What regulatory pathway was followed for the FDA clearance of the Kodak X-Omat Processor Model ME-3, and what does this mean for users?

  The Kodak X-Omat Processor Model ME-3 received FDA clearance through a Traditional 510(k) pathway, classified under Product Code IXW and reviewed by the Radiology (RA) Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness in radiographic-film processing. For users, this clearance indicates the processor adheres to FDA’s special controls for automatic radiographic-film processors, providing confidence in its regulatory compliance.