# K143586: FACT Medical Imaging Sysytem

- Pathway: 510(k) (Traditional)
- Applicant: Dexin Medical Imaging Technology Co., Ltd.
- Decided: Sep 2, 2015 after 258 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 5.
- K120484: Visia Oncology, MeVis Medical Solutions AG (2012) Summary page 5.
- K083227: Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics, Inc. (2008) Summary page 5.

## Indications for 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.

Source page: https://510kreport.com/device/K143586
Methodology: https://510kreport.com/methodology