(55 days)
The IntraX Film Processor is an Automatic film processor used by dental offices to develop x-ray films. all sizes of intra - oral film .
IntraX Film Processor
Trade Name: IntraX Film Processor
Common Name: Automatic Film processor
Classification name: Processor, Radiographic-Film, Automatic
Device Class 2
Regulation Number: 892.1900
This is a 510(k) summary for a radiographic film processor, not an AI/ML medical device. Therefore, the information typically requested in questions 1 through 9 (related to acceptance criteria, study design, ground truth, and human-in-the-loop performance for AI/ML devices) is not applicable or present in this document.
The document describes a traditional medical device (IntraX Film Processor) and its substantial equivalence to predicate devices, focusing on regulatory classification, indications for use, and general controls provisions of the FDA. It does not contain information about AI/ML algorithm performance, test sets, training sets, or expert adjudication that would be used to assess an AI/ML-driven device.
§ 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.