Kodak X-Omat Model 180 LP Processor

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

510(k) Number

K921269 ↗

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 MODEL 180 LP PROCESSOR used for?

  This device is an automatic radiographic-film processor designed for processing radiographic film in medical imaging applications, specifically in radiology settings where consistent film development is required.

• How is the KODAK X-OMAT MODEL 180 LP PROCESSOR supplied and intended for use?

  It is supplied as a reusable processor, meaning it is designed for repeated use in radiology environments rather than as a single-use disposable item, allowing for ongoing film processing with proper maintenance.

• What regulatory clearance does the KODAK X-OMAT MODEL 180 LP PROCESSOR have?

  The device received FDA 510(k) clearance under submission number K921269, which confirms it is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device with product code IXW.