(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.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.