Kodak X-Omat M43A, M43, & Clinic 1 Processors

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

510(k) Number

K934350 ↗

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 X-Omat M43A used for?

  The Kodak X-Omat M43A is an automatic radiographic-film processor designed to chemically develop and process exposed X-ray films into visible diagnostic images. It is specifically intended for use in radiology departments, including smaller hospital satellite units, where space efficiency is important. The processor transforms latent images on film into interpretable results for radiologists.

• Are the Kodak X-Omat M43A, M43, and Clinic 1 processors single-use or reusable?

  These processors are reusable medical devices. They are built for repeated use in radiology settings but require regular maintenance, cleaning, and servicing as outlined in the manufacturer’s operator and service manuals. Proper upkeep ensures consistent performance and extends the device’s operational lifespan.

• What film sizes do the Kodak X-Omat M43A, M43, and Clinic 1 processors handle?

  The processors are engineered to handle standard radiographic film sizes commonly used in radiology imaging. While the exact specifications for each model (M43A, M43, or Clinic 1) are detailed in the manufacturer’s documentation, they are designed to accommodate typical widths and lengths required for diagnostic X-ray films, ensuring compatibility with conventional radiology workflows.

• Do the Kodak X-Omat processors come sterile, and how should they be stored?

  The Kodak X-Omat M43A, M43, and Clinic 1 processors are not sterile devices. They are reusable and must be cleaned and serviced according to the manufacturer’s guidelines to maintain hygiene and functionality. Storage should follow the instructions provided in the operator manual, typically in a clean, dry environment away from direct sunlight or extreme temperatures to preserve the processor’s components and chemical systems.

• What regulatory clearance does the Kodak X-Omat M43A processor have in the U.S.?

  The Kodak X-Omat M43A processor holds FDA 510(k) clearance under the reference number K934350, confirming its substantial equivalence to predicate devices. This clearance falls under the regulatory category for radiographic film processing systems (Device Class II) and was granted by the FDA’s Radiology (RA) Advisory Committee in 1994, ensuring compliance with U.S. medical device standards.