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510(k) Data Aggregation
K Number
K143586Device Name
FACT Medical Imaging Sysytem
Manufacturer
Date Cleared
2015-09-02
(258 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Dexin Medical Imaging Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FACT Medical Imaging System is a medical software application that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The FACT Medical Imaging System is not meant for primary image interpretation in mammography. In addition, the FACT Medical Imaging System has the following indications:
(1) Pulmonary Review and Analysis Application
Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow.
The automated image registration facilitates the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The summary report of findings helps the user to track findings and note changes, such as shape, size, or overtime.
(2) Vessel Review and Analysis Application
Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries.
Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, curved MPR vessel view, and straightened MPR view with cross sections of the vessel. Physicians can semi-automatically stenosis measurements, and maximum and minimum lumen diameters. In addition, physicians can also measure vessel dimensions along the centerline in curved MPR view and examine Hounsfield unit or signal intensity statistics.
Device Description
The FACT Medical Imaging System is self-contained, non-invasive medical image processing software. It can be marketed as software only, as well as packaged with standard off-the-shelf PC hardware. It can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network.
The FACT Medical Imaging System allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. This device addresses physicians' needs through various application options for pulmonary and vessel applications.
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