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The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging.

The Voxar 3D product family provides several levels of functionality to the user .-

• Basic analysis tools they use on a daily basis, such as 2D review, orthogonal . multi planar reconstructions (mpr's), oblique mpr's, curved / cross - curved MPR's, slab MPR's AveiP, MIP, MinIP, measurements, annotations, reporting, distribution, etc.
• Tools for in depth analysis, such as segmentation, enescopic review, colour VR . slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc
• Specialist tools and workflow enhancements for specific clinical applications . which provide targeted workflows, custom UI, targeted measurement and reporting functions including colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), calcium scoring (which is intended for non - invasive identification and quantification of calcifieatherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel analysis (which is intended for the qualative and quantative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc

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This device is a Picture Archiving and Communications System (PACS) component. The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details about de novo studies proving new acceptance criteria.

The document indicates that the Voxar 3D Product Family is intended to "aid them in reading and interpreting DICOM compliant tomographic medical imaging." It lists various functionalities such as 2D review, MPRs, MIP, MinIP, measurements, annotations, reporting, distribution, segmentation, endoscopic review, 3D volume review, and specialist tools for applications like colon screening, calcium scoring, and vessel analysis.

Crucially, the document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This statement implies that the device's acceptance criteria are primarily met by demonstrating its equivalence to existing, legally marketed devices.

Therefore, the provided text does not contain the specific information required to answer your questions regarding acceptance criteria, a study proving those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in a clinical study report or a more detailed technical report which is not included in this 510(k) clearance letter.

Without a detailed study report describing performance against acceptance criteria, I cannot provide the requested table or answer points 2 through 9. The letter confirms a 510(k) number (K043194) and makes a substantial equivalence determination based on the provided indications for use and a comparison to predicate devices.

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