(13 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.
The object of this device is total patient populations.
Exposure can be captured on film, CR or Digital Radiography (DR)
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the Shimadzu MUX-100D Series mobile x-ray system. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices. This type of submission (510(k)) focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than on proving its performance against specific acceptance criteria in a detailed clinical study for novel claims.
Therefore, I cannot extract the requested information from this document.
§ 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.