3DICOM MD Cloud

3DICOM MD Cloud is a web-based software medical device for diagnostic viewing and analysis of multi-modality DICOM medical images (CT, MRI, X-ray, ultrasound, PET) in a secure cloud environment. Qualified healthcare professionals can view patient images, manipulate them, create markups, perform 2D measurements, and generate DICOM-structured reports. It is not intended for diagnostic use with mammography images or on mobile devices.

The device is a cloud-hosted web browser viewer (Windows, macOS, Linux) that ingests DICOM objects from 3DICOM cloud storage. Key features include 2D multi-planar viewing and 3D visualization, window/level adjustments, measurement tools (line, poly-line, rectangle, angle, ROI, circle, ellipse, Cobb angle), text annotations, PDF report generation, and session sharing. Unlike the primary predicate FlexView Diagnostic, it does not directly connect to institutional PACS/VNA networks but instead uses cloud storage integration.

Software verification and validation were performed in accordance with FDA guidance 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (June 2023), including measurement accuracy and usability tests. Cybersecurity requirements, risk analysis, and mitigation followed FDA guidance 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission' (June 2025).

3DICOM MD Cloud is substantially equivalent to FlexView Diagnostic (primary predicate, K233226) based on identical intended use/indications with same mammography and mobile-device limitations, comparable technological characteristics as medical image management and processing systems (21 CFR 892.2050, product code LLZ), and demonstrated non-clinical performance through software V&V and risk management. Observed differences (UI layout, cloud architecture, PET support, session sharing) do not raise new safety or effectiveness questions.