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The DR-ER version of Canon's X-ray Digital Cameras 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.

The Canon X-ray digital camera model CXDI-11 DR-ER add. version is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The Canon X-ray digital camcra model CXDI-22 DR-ER add. version is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capure for conventional film/screen radiographic examinations.

The Canon X-ray digital camera model CXDI-31 DR-ER add. version is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The provided text describes three different Canon X-ray Digital Camera models (CXDI-11 DR-ER, CXDI-22 DR-ER, and CXDI-31 DR-ER), all referenced under K023586. However, the documentation does not contain specific acceptance criteria or details of a study proving the devices meet such criteria. It primarily focuses on demonstrating substantial equivalence to their respective predicate devices.

The documents are 510(k) summaries for new versions of existing X-ray digital cameras, stating their intended use is to replace film/screen systems in general diagnostic procedures. The FDA's letter (Document 3 and 4) confirms the substantial equivalence determination but does not provide details of performance studies or acceptance criteria beyond regulatory compliance.

Therefore, I cannot provide the requested information from the given text. The provided documents are administrative in nature for FDA clearance and do not contain the technical study details needed to answer the prompt.

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