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The MDMC-12133 is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is especially designed for breast tomosynthesis applications.

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The provided text is a 510(k) premarket notification letter from the FDA to BARCO N.V. concerning their device MDMC-12133, a Picture Archiving and Communications System (PACS). The letter indicates that the device is intended for displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis, with a special design for breast tomosynthesis applications.

However, the document is an FDA approval letter and does not contain the detailed study information necessary to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies. The letter confirms substantial equivalence to a predicate device and states the intended uses but does not include the underlying technical or clinical validation studies.

Therefore, I cannot provide the requested information based solely on this document. To answer your questions, additional documentation such as the 510(k) submission summary, a clinical study report, or a detailed technical specification document would be required.

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