Kodak 100-J & 100-K Chemical Mixers

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K911713 ↗

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 are the Kodak 100-J & 100-K Chemical Mixers used for?

  These devices are designed specifically for mixing chemical solutions—developer and fixer—used in radiographic film development within automated radiographic-film processors. Their purpose is to ensure consistent and precise chemical formulation, which is critical for reliable film processing in radiology departments.

• Are the Kodak 100-J & 100-K Chemical Mixers reusable or single-use?

  The Kodak 100-J & 100-K Chemical Mixers are supplied as reusable equipment. They are not intended for single-use and are built to withstand repeated use in automated radiographic-film processing systems, provided they are maintained according to manufacturer guidelines.

• Are these mixers sterile?

  No, the Kodak 100-J & 100-K Chemical Mixers are not sterile. They are designed for use in radiology departments where chemical mixing occurs outside sterile environments, and no sterility claims are made for these devices.

• What regulatory pathway applies to these chemical mixers?

  The Kodak 100-J & 100-K Chemical Mixers are classified as Class II medical devices under FDA regulations and were cleared via the traditional 510(k) review pathway (K911713). They fall under the product code IXW for processors in radiology, ensuring compliance with FDA standards for radiographic-film processing equipment.

• Which radiology departments would benefit most from these mixers?

  These mixers are ideal for radiology departments that use automated radiographic-film processors and require precise, automated mixing of developer and fixer chemicals. Their design supports consistent film processing, which is essential for diagnostic imaging quality in clinical settings where film-based radiography is still utilized.