Kodak M35A-M X-Omat Processor

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

510(k) Number

K901772 ↗

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 M35A-M X-OMAT PROCESSOR used for?

  The KODAK M35A-M X-OMAT PROCESSOR is used to process medical x-ray sheet or roll film in radiology settings. It automatically develops and fixes the film using KODAK RP X-OMAT Developer Replenisher and KODAK RP X-OMAT Fixer and Replenisher, enabling timely image production for diagnostic purposes.

• How is the KODAK M35A-M X-OMAT PROCESSOR supplied and what are its requirements for operation?

  The device is supplied by Eastman Kodak Company and requires KODAK RP X-OMAT Developer Replenisher and KODAK RP X-OMAT Fixer and Replenisher to operate. It is designed for use in radiology facilities where consistent chemical replenishment and film processing are needed.

• Is the KODAK M35A-M X-OMAT PROCESSOR intended for single-use or reuse, and what is its regulatory classification?

  The KODAK M35A-M X-OMAT PROCESSOR is a reusable automatic processor designed for repeated use in processing multiple films. It is classified as a Class II medical device under regulation number 892.1900 and received FDA 510(k) clearance under K901772, indicating it is substantially equivalent to a legally marketed predicate device.