(117 days)
To be used for processing of radiographed films.
Developing exposed x-ray film.
Designed solely for processing of radiographed films, by roller transport system and by use of developer/fixer solutions(that are to be locally obtained).
The provided document is a 510(k) summary for a Radiographic Film Processor and does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it is a traditional medical device (film processor) and not an AI/ML-based device.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from this document. The document focuses on the physical characteristics, intended use, and non-clinical tests for electrical safety and performance of the film processor.
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.