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This Digital Mobile Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

These are modified versions of the predicate mobile digital diagnostic x-ray systems. They feature motorized movement and full battery operation. Various Canon digital X-ray panels are supplied with the system. The Mobile X-Ray Unit MOVIX DReamy has a Basic configuration or Advanced configuration. The Mobile X-Ray unit MOVIX DReamy is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on MOVIX DReamy and it is displayed on touch screen. The MOVIX DReamy Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit MOVIX DReamy. This X-Ray generator for MOVIX DReamy Mobile X-Ray Unit has a radiogenic unit mounted on head-assembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit MOVIX DReamy is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES: XRR-3331 insert and E7886 insert. The Manual Beam Limiting Device is from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.

Based on the provided text, the MOVIX DReamy device is a mobile X-ray system. The document does not describe acceptance criteria for an AI/ML device or a study proving that the device meets such criteria. Instead, it is a 510(k) premarket notification for a mobile X-ray system, establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them based on the given document. The document describes the device, its intended use, comparison to a predicate device, and compliance with various international standards, but it explicitly states that no clinical testing was required to establish substantial equivalence.

The relevant sections for this request (AI/ML acceptance criteria and performance study) are not present in this document because it pertains to a different type of medical device clearance.

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