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The FDR AcSelerate system is a configurable stationary overhead X-ray tube and stand/table system intended to be used by a qualified/trained doctor or technologist for taking general radiographic and tomographic exposures of the whole body. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The FDR AcSelerate is not intended for mammography. The FDR AcSelerate uses an integrated digital detector for generating diagnostic images by converting X-rays into electronic signals.

The FDR AcSelerate system is a configurable stationary overhead X-ray tube and stand/table system intended to be used by a qualified/trained doctor or technologist for taking general radiographic and tomographic exposures of the whole body. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The FDR AcSelerate is not intended for mammography. The FDR AcSelerate uses an integrated digital detector for generating diagnostic images by converting X-rays into electronic signals.

This document is a 510(k) clearance letter for the "FDR AcSelerate Stationary X-ray System." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information regarding acceptance criteria, study details, or performance data for the device.

Therefore, I cannot provide the requested table and study information based on the provided text. The document is an administrative clearance, not a clinical or performance study report.

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