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510(k) Data Aggregation
K Number
K112096Device Name
IMAGELINK
Manufacturer
Date Cleared
2011-09-30
(70 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
COMPUTER PROGRAMS AND SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ImageLink™ is an integrated medical imaging solution that allows for the storage, manipulation, and annotation of high resolution digital radiological images from multiple source modalities. It enhances the efficiency of diagnostic decision making and includes a feature-rich viewer with customizable worklists and hanging protocols that can be organized to meet the unique requirements and style of the individual radiologist.
Device Description
ImageLink is designed to fit seamlessly into the hospital's existing IT infrastructure, integrating with the CPSI HIS/RIS systems. Patient and order information is shared with CPSI clinical applications providing real-time update of the PACS worklist and DICOM Modality Worklist files, notification of completed orders and signed transcriptions, and quick access to the study throughout the enterprise.
This product conforms to recognized industry standards such as DICOM, JPEG, ACR, and others as applicable.
Support for the following modalities will be provided:
- · CR
- · CT
- · MR
- · NM
- RF
- US
- DX
- PT
- XA
- · OT
- · MG
The CPSI ImageLink application software includes the following major components: ImageLink Server, ImageLink Viewer, and ImageLink/ChartLink Interface for web viewing. These software applications, combined with the hardware platform and networking infrastructure, make up the ImageLink System.
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