JLK-AILink is a software platform designed to help healthcare professionals manage, view, and share medical images from various imaging devices like CT and MRI scanners. It enables efficient processing and annotation of images and supports remote access through mobile devices, enhancing clinical workflows and facilitating timely decision-making for patient care.
Intended Use
JLK-AILink is a software that receives digital images and data from various sources (i.e., CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and analyzed data with optional modules can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals including but not limited to physicians and medical technicians. The device is not intended for mammography.
Technology
JLK-AILink is a software that facilitates bidirectional communication with hospital PACS systems and imaging equipment such as MR, CT, or X-ray scanners via DICOM standard. It integrates a DICOM viewer with image manipulation and annotation tools and supports modular architecture for integration of optional analysis solutions. The system also supports mobile access and compatibility with containerized environments for data security and management.
Performance
The device underwent extensive software verification and validation testing, including functionality, risk management, cybersecurity, and requirements verification. Test results demonstrated that the system accurately performs under clinically relevant parameters and meets acceptance criteria for its intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/6/2025
19 days - 2
FDA Approval
2/25/2025
Other devices from JLK, Inc.
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