FACT Medical Imaging Sysytem
by Dexin Medical Imaging Technology Co., Ltd. 510(k)
Active
510(k) K143586
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143586 | Date2 Sep 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The FACT Medical Imaging System is a radiology image processing software designed for the acquisition, processing, review, and communication of multi-dimensional digital images. Classified under the FDA’s LLZ product code, it falls within the category of advanced image processing systems and is adjacent to Picture Archiving and Communication Systems (PACS). This system enables medical professionals to analyze, manipulate, and share imaging data from various modalities, facilitating diagnostic workflows in radiology settings.
Supplied as a software application, the FACT Medical Imaging System is intended for use in clinical environments where digital imaging data must be processed and distributed. It is not described as single-use or reusable, nor is sterility or MRI safety applicable, as it is a non-physical, software-based solution. The system holds an FDA 510(k) clearance (K143586) under the Traditional review pathway, classified as substantially equivalent (SESE) within the Radiology advisory committee’s purview. No additional regulatory markings or certifications are stated beyond the provided clearance.
Questions
AI-generated answers, 1 Oct 2026
What is the FACT Medical Imaging System used for?
The FACT Medical Imaging System is a radiology software solution designed to handle the acquisition, processing, and communication of multi-dimensional digital images. It supports workflows by enabling medical professionals to analyze, manipulate, and share imaging data from various modalities—such as X-ray, CT, or MRI—within clinical environments. This reduces manual handling of images and improves diagnostic efficiency by centralizing data management.
How is the FACT Medical Imaging System supplied?
The FACT Medical Imaging System is supplied exclusively as a software application. It does not require physical hardware or consumables, making it a non-physical, digital tool for radiology departments. Installation and updates are managed through standard IT infrastructure, ensuring compatibility with existing hospital networks and imaging systems.
Is the FACT Medical Imaging System single-use or reusable?
The FACT Medical Imaging System is not designed for single-use or reuse in the traditional sense, as it is a software-based solution. Instead, it is intended for continuous use within clinical settings, with periodic software updates to maintain functionality, security, and compliance with evolving medical imaging standards. Licensing typically allows for long-term deployment in a single facility.
What regulatory clearance does the FACT Medical Imaging System hold?
The FACT Medical Imaging System holds an FDA 510(k) clearance (K143586) under the Traditional review pathway, classified as substantially equivalent (SESE) to predicate devices. This clearance was granted by the FDA’s Radiology Advisory Committee (RA) and falls under the LLZ product code, confirming its compliance with U.S. regulatory standards for advanced image processing systems.
Does the FACT Medical Imaging System support integration with other imaging systems?
While the provided description does not explicitly detail integration capabilities, the FACT Medical Imaging System is positioned as an advanced image processing tool adjacent to Picture Archiving and Communication Systems (PACS). This suggests it is designed to interface with existing digital imaging infrastructure, enabling seamless data acquisition, processing, and distribution across modalities. Compatibility would depend on the specific IT environment and may require technical validation during implementation.