Kodak Medical X-Ray Developer & Replen.

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

510(k) Number

K801209 ↗

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 is the Kodak Medical X-Ray Developer & Replenisher used for?

  This device is a chemical solution kit designed specifically for automatic radiographic-film processors. It replenishes depleted developer and fixer chemicals during film processing to ensure clear, accurate medical imaging results. By maintaining consistent chemical levels, it supports continuous workflows in radiology departments.

• How is the Kodak Medical X-Ray Developer & Replenisher supplied and used?

  The kit is supplied as a ready-to-use chemical solution intended for integration into automated radiographic-film processors. It can be used either as a single-use replacement or as a replenishment solution for ongoing processing. The exact usage depends on the processor’s configuration and the manufacturer’s instructions for chemical management.

• Is the Kodak Medical X-Ray Developer & Replenisher sterile?

  No, this device is not sterile. It is a chemical solution intended for integration into processors and is not packaged or handled under sterile conditions. Sterility is not required for its intended use in radiographic-film development.

• Can the Kodak Medical X-Ray Developer & Replenisher be reused?

  The device is designed for single-use or replenishment in continuous processing workflows. While the chemical solution itself may be replenished incrementally, the kit itself is not intended for repeated use without following the manufacturer’s guidelines for chemical replenishment and processor maintenance.

• What storage and handling precautions should be taken for this product?

  The Kodak Medical X-Ray Developer & Replenisher should be stored and handled according to standard chemical safety protocols for radiographic processing solutions. This includes keeping it in a cool, dry place away from direct sunlight, ensuring proper ventilation, and following manufacturer instructions for shelf life and disposal. No specific MRI safety considerations apply, as it is not intended for use in MRI environments.