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The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging. Such small field imaging is used during stereo tactic biopsy and diagnostic spot localization.

OPDIMA is a Small Field Digital Mammography (SFDM) system. It is marketed as an option to the Siemens MAMMOMAT series X-ray examination systems. It provides spot imaging for diagnosis and stereo tactic biopsy. OPDIMA features a small (49 x 85 mm²) CCD detector that converts the X-ray attenuation into an electronic pattern. The electronic pattern is read out, processed and displayed at a high resolution monitor. The images may be post processed, printed or transferred via DICOM network for multiple purposes.

The provided text is a 510(k) summary for the OPDIMA Digital Mammographic X-ray System. It details the device's description, intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) K071015 primarily states that the updated OPDIMA with a Windows-based workstation is substantially equivalent to the previously cleared OPDIMA with a UNIX workstation (K003945). The justification for substantial equivalence is based on the hardware, control software, image processing, and intended use remaining the same, with only the graphical user interface and performance being improved due to a technology leap (moving to Windows from UNIX).

Therefore, I cannot populate the requested information from the provided text. The document is for a "software update" or "workstation update" to an existing device, and the focus is on maintaining equivalence rather than introducing a new device with new performance criteria to be met through a specific study.

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