CCI PACS VIEWER (PACS-US-001)

The CCI PACS VIEWER is a software-based Medical Image Management and Processing System (MIMPS) that archives, distributes, retrieves, processes, and displays medical images from DICOM-compliant modalities (CT, MRI, PET, ultrasound, X-Ray). It provides healthcare professionals with tools for interactive display, manipulation, measurement, annotation, and comparison of images to aid in diagnostic review and clinical consultation. The device is intended for use by trained and licensed healthcare professionals, including radiologists for primary diagnostic interpretation and physicians or technicians for clinical review, and is restricted to prescription use only.

The CCI PACS VIEWER operates on a cloud-based virtual platform with Windows OS accessible via HTML5 browsers on desktop, laptop, or mobile devices. It supports 2D and 3D imaging, multi-planar reconstruction (MPR), measurement tools (distance, area, angle, ROI, volumetry with SUV for PET), annotations, and DICOM 3.1 compliance (NEMA PS 3.1–3.20 2024e). For primary diagnostic use, display monitors must be FDA-cleared. The device does not support primary mammography interpretation, advanced quantitative tissue characterization, or automated detection/diagnosis; it is not intended for diagnostic use on mobile devices like iPhones and iPads.

Software verification and validation conducted per FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (June 2023), IEC 62304:2006/Amd 1:2015 (Class B), ISO 14971:2019 (risk management), DICOM PS 3.1–3.20, and HL7 for healthcare data exchange. Non-clinical bench testing included accuracy verification for measurement tools, display fidelity, and DICOM compliance across supported modalities.

The CCI PACS VIEWER is substantially equivalent to the predicate device (IBM iConnect Access, K203104) and reference device (OmegaAI Image Viewer, K222476) because it shares the same regulatory classification (Class II, 21 CFR 892.2050), product code (LLZ), and intended use as a general-purpose MIMPS viewer with no novel diagnostic claims. Non-clinical bench performance testing demonstrates equivalent technological characteristics, functional performance, and DICOM compliance; biological characteristics are not applicable since all three devices are software with no body-contacting components. Risk management per ISO 14971:2019 shows clinical benefits of improved image accessibility and interoperability outweigh residual risks reduced to ALARP.