Search Results
Found 1 results
510(k) Data Aggregation
K Number
K201172Device Name
CFP-3131, CFP-2222
Manufacturer
Date Cleared
2020-05-29
(28 days)
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
MX Imaging, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use in radiographic fluoroscopic applications including cardiar, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Device Description
These CMOS X-ray detectors feature: The MX Imaging CMOS Flat Panel Detectors are designed for medical x-ray imaging applications. The CMOS panels are real-time x-ray detectors. The Detectors use a state of the art CMOS Imaging sensor that is based on a special pixel architecture enabling the detectors to be used in high sensitivity applications such as x-ray fluoroscopy/pulsed fluoroscopy, as well as applications requiring a large dynamic x-ray range such as radiography serial and radiography applications. The CMOS Flat Panel Detector is a component, and forms the part of a complete fluoroscopic x-ray system. The CMOS Detector interfaces to the Host X-Ray System through the associated interface connectors on the flat panel. The CMOS Flat Panel Detector is also synchronized to the X-Ray Generator via the interface cables. The intended use for this device is for Image Intensifier replacement in legacy surgical C-Arm systems.
Ask a Question
Ask a specific question about this device
Page 1 of 1