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DIGITAL RADIOGRAPHY CXD1-70C Wireless provides digital image capture for conventional film/screen radiographic examinations.

The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-70C Wireless is a solid state x-ray imager which has approx. 35x43cm imaging area.

The DIGITAL RADIOGRAPHY CXD1-70C Wireless intercepts x-ray photons and the scintillator of the CXDI-70C Wireless emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals.

After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless.

This submission describes a new model of a digital radiography system, the Canon CXDI-70C Wireless, which is intended to replace conventional film/screen radiographic systems. The submission asserts substantial equivalence to predicate devices (Canon CXDI-55C and CXDI-31). However, the provided document does not contain any information regarding specific acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on:

• Identifying the device and its intended use.
• Comparing it to predicate devices, stating that its imaging principle and intended use are the same, and that most specifications are "the same or better."
• The FDA's decision of substantial equivalence based on the provided information, similarity to predicates, and design control activities/non-clinical testing.

Therefore, I cannot provide the requested information from the given text. The relevant sections for performance data are missing.

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