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Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostics in the field of cardiology or radiology by means of enabling visualization and measurement of structures of the heart and vessels for:

• Pre-operational planning and sizing for cardiovascular interventions and surgery
• Postoperative evaluation
• Support of clinical diagnosis by quantifying dimensions in coronary arteries
• Support of clinical diagnosis by quantifying calcifications (calcium scoring)

To facilitate the above, the 3mensio Workstation provides general functionality such as:

• Segmentation of cardiovascular structures
• Automatic and manual centerline detection
• Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AIP, MinIP
• Measurement and annotation tools
• Reporting tools

3mensio Workstation is an image post-processing software package for advanced visualization and analysis for diagnostics in the field of cardiology and radiology and offers functionality to view CT/X-Ray angiographic and ultrasound images, to segment cardiovascular structures in these images and to analyze and quantify these cardiovascular structures and to present the results in different formats.

3mensio Workstation can be deployed as a web-based solution intended for usage in a network or cloud environment or as a standalone package and runs on a PC with a Windows operating system. It can read DICOM images from an accessible file system, hard disk (local directory), or (indirectly) received from the CT or PACS system. 3mensio Workstation provides the functionality to import the DICOM images and to organize the loaded DICOM images into patients, studies, and series.

3mensio Workstation contains two analysis modules: 3mensio Vascular and 3mensio Structural Heart:

• 3mensio Vascular enables assessment of vessels and can help to measure calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures.

• 3mensio Structural Heart enables assessment and measurement of different structures of the heart, e.g., the heart valves, coronary arteries and the ventricles. It provides analysis of different approach routes to cardiovascular structures for replacement or repair procedures. In addition, it can help in the quantification of calcifications.

Results can be displayed on the screen, printed, or saved in a variety of formats to hard disk, network or PACS system. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats.

This document describes the FDA 510(k) clearance letter for the 3mensio Workstation. The following information is extracted and organized as requested.

Acceptance Criteria and Device Performance Study for 3mensio Workstation (K250330)

The 3mensio Workstation is a medical image analysis software intended for advanced visualization and quantitative analysis for diagnostics in cardiology or radiology. It provides functionalities for pre-operational planning, postoperative evaluation, and support of clinical diagnosis through quantifying dimensions and calcifications in cardiovascular

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