Merge PACS
Merge Healthcare IncorporatedMerge PACS is a software system that helps medical professionals view, analyze, and manage images from various medical imaging modalities such as CT, MRI, PET, ultrasound, and mammography. It supports diagnostic reading, reporting, and communication workflows, enabling clinicians to efficiently handle patient imaging studies and related data. It includes advanced image manipulation tools and workflow management features to assist radiologists and other medical staff.
Intended Use
Merge PACS is a Picture Archiving and Communication System (PACS) for multi-modality image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data.
Technology
Merge PACS is a software medical device running on standard computer hardware. It integrates with imaging archives and hospital systems via DICOM and HL7 protocols. It provides image manipulation tools including linking, MPR, MIP, 3D image fusion and registration of CT, MR, and PET, CVR, and measurements like SUV calculation. The system supports lossless and lossy compression and operates through web-based and local access.
Performance
Merge PACS underwent quality assurance including risk analysis, design reviews, unit and integration testing, and performance testing. It complies with international and FDA-recognized standards, including DICOM standards. Cybersecurity aspects are addressed. No animal or clinical testing was required, and no new safety or effectiveness issues were identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/9/2019
1 month - 2
FDA Approval
10/17/2019
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