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K Number
K992037
Device Name
MAMEX
Manufacturer
DEL MEDICAL IMAGING CORP.
Date Cleared
1999-07-30

(44 days)

Product Code
IZH
Regulation Number
892.1710
Type
Special
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The option intended to provide the operator with the capabilities of selecting Rhodium filtration for enhanced image quality.

Device Description

Rhodium filtration option for use with "Mamex" Mammographic X- Ray system.

AI/ML Overview

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.

§ 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.