(64 days)
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)
Mobile x-ray system
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Medical Systems regarding their MobileDaRt Evolution device. This document confirms the substantial equivalence of the device to legally marketed predicate devices.
However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, or ground truth establishment. The letter is purely an administrative communication confirming market clearance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.