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The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.

Automatic Radiographic Film Processor. This film processor is operates like most predicate devices in that it uses a series of transport rollers to pull film through a series of open developer solution, fixer solution, and wash water tanks. Developer and fixer solution temperature is controlled automatically by a computer board. No plumbing is required.

This document is a 510(k) summary for an X-ray film processor. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a regulatory submission for premarket notification of a medical device to the FDA, demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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