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510(k) Data Aggregation
K Number
K993740Device Name
MAMEXManufacturer
Date Cleared
1999-11-26
(22 days)
Product Code
Regulation Number
892.1710Type
SpecialPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Provide the capabilities of performing upright biopsy.
Device Description
Mamex (Mammography System)
AI/ML Overview
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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