FDA Clears CliniComp PACS Viewer for Integrated Diagnostic Imaging

July 07, 2026
The FDA has granted clearance for CliniComp's PACS Viewer, allowing diagnostic-quality image viewing and processing within its New Era EHR platform. The system consolidates imaging, clinical workflows, and AI-based decision support into a single patient record.

CliniComp announced in a press release that its Picture Archiving and Communication System (PACS) Viewer has received FDA 510(k) clearance as a Medical Image Management and Processing System. The approval enables diagnostic-quality image viewing and advanced image processing directly within CliniComp's New Era EHR platform.

The PACS Viewer allows clinicians to view, manipulate, and analyze diagnostic images from within a patient's electronic health record, eliminating the need to switch between separate systems. It integrates imaging studies with data such as laboratory results, vital signs, medications, and patient history.

The system includes diagnostic imaging with high-fidelity viewing, unified clinical context, embedded AI capabilities, and automated prioritization of high-acuity studies based on real time patient data. Built on CliniComp's enterprise architecture, the cleared PACS Viewer enables a single longitudinal patient record and supports faster access to diagnostic information for healthcare providers.

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