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510(k) Data Aggregation
(22 days)
Provide the capabilities of performing upright biopsy.
Mamex (Mammography System)
The provided text is a 510(k) clearance letter from the FDA for a mammography system named "Mamex." This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The letter only states that the device is substantially equivalent to legally marketed predicate devices.
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(44 days)
The option intended to provide the operator with the capabilities of selecting Rhodium filtration for enhanced image quality.
Rhodium filtration option for use with "Mamex" Mammographic X- Ray system.
This is a 510(k) premarket notification for a Rhodium filtration option for a mammographic x-ray system. The FDA letter is a declaration of substantial equivalence to legally marketed predicate devices. The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text.
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