(87 days)
THE Ax200 is intended to develop medical x-ray film.
AX200 Automatic X-Ray Film Processor Model # 6586.03
The provided document is a 510(k) premarket notification letter from the FDA regarding an automatic x-ray film processor (AX200, Model #6586.03). This type of document confirms that the device is substantially equivalent to a legally marketed predicate device and allows it to be marketed.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding the performance of the device.
The letter focuses solely on the regulatory approval process and does not delve into the technical validation or clinical study results that would typically include the requested information.
Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based on the given input.
§ 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.