Kodak X-Omat FS-1A Processor

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

510(k) Number

K923552 ↗

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 radiographic film can the Kodak X-Omat FS-1A Processor develop, and is it suitable for all radiology departments?

  The Kodak X-Omat FS-1A Processor is designed specifically for developing radiographic film used in radiology settings. While it automates the chemical processing steps to produce high-quality images, the exact compatibility with film types depends on the manufacturer’s specifications for the film being used. It is intended for general radiology departments where consistent and efficient film development is required, but users should confirm compatibility with their specific film brands and types to ensure optimal results.

• Is the Kodak X-Omat FS-1A Processor reusable, and if so, what maintenance is required to keep it functioning properly?

  Yes, the Kodak X-Omat FS-1A Processor is a reusable device, not intended for single-use. To maintain performance, it requires proper maintenance and calibration, as noted in its description. This includes regular cleaning, chemical replenishment, and adherence to manufacturer guidelines for upkeep to ensure consistent image quality and longevity of the equipment.

• How is the Kodak X-Omat FS-1A Processor regulated, and what does its FDA clearance mean for users?

  The Kodak X-Omat FS-1A Processor was cleared by the FDA under a 510(k) submission (K-number K923552) in 1992, demonstrating it is substantially equivalent to a legally marketed device. This clearance indicates that the processor meets regulatory standards for radiographic film processing equipment, but users should follow the manufacturer’s instructions and maintenance protocols to ensure continued compliance and performance.

• Is the Kodak X-Omat FS-1A Processor sterile, and if not, what precautions should be taken during use?

  The Kodak X-Omat FS-1A Processor is explicitly described as a non-sterile medical instrument. Since it is reusable and used in radiology departments, standard infection control practices—such as proper cleaning between uses and adherence to facility protocols—should be followed to minimize contamination risks and maintain a safe working environment.