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The mammographic X-ray unit model MGF101 and MGF110, is a mammographic imaging system for screening and diagnostic examinations. The unit can also be adapted for biopsy and spot mammographic examinations.

Mammography X-ray equipment models MGF101 and MGF110, Commercial names: Alpha III, Alpha ST, Alpha RT and Alpha IQ

The provided text is a 510(k) clearance letter from the FDA for mammography X-ray equipment (models MGF101 and MGF110, commercial names Alpha III, Alpha ST, Alpha RT, and Alpha IQ). This document is a regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to devices marketed before May 28, 1976, and outlines the regulatory class and general controls provisions of the Act. It mentions the "Indications For Use" which describes the intended purpose of the device (mammographic imaging system for screening, diagnostic, biopsy, and spot mammographic examinations), but it does not detail performance metrics or study results.

Therefore, I cannot provide the requested information based on the input text. The input only provides regulatory approval details, not technical performance or study data.

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