(29 days)
This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel.
This document describes the regulatory submission for the Universal DR 1748, an upgrade kit for digital X-ray systems. It asserts substantial equivalence to a predicate device, the Konica Minolta SKR 3000 (K210619). The primary difference is the digital X-ray panel and associated software.
However, the provided text does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria and the detailed study that proves the device meets those criteria for the AI/Software component (Ultra software).
The mention of the "Ultra" software suggests it is a crucial component of the new system, having been previously cleared (K212291). The relevant part states: "The digital panel software employed was used unmodified from clearance obtained from FDA. The software has been validated as a control for CPI and Sedecal diagnostic x-ray generators."
This means that the software's performance and validation were established in its prior clearance (K212291) and are not re-evaluated in detail within this specific K214030 submission summary. The current submission focuses on the integration of this pre-cleared software with new hardware components (the Venu1748V digital panel).
Therefore, based solely on the provided text, I cannot extract the specific details about the acceptance criteria and the study proving the software's performance. The document only confirms that the software was "unmodified" from a previously cleared version and "validated as a control" for certain generators.
To provide the requested information, one would need to access the K212291 submission for the "Ultra" software, as that is where its performance studies would have been detailed.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.