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Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.

Diagnostic Review Workstations - Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and interactive manipulation of multi-modality softcopy images.

Two and three-dimensional image coregistration (fusion) and segmentation of multiple imaging modality data including but not limited to functional MRI, PET, SPECT, and CT for user-selected regions of interest taken at different time points or generated using different scanning protocols.

Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies (c.g., tumors, abscesses, AVMs), or other anatomical structures. The software can help track changes in morphology, functional activity, or other responses that may occur as a result of treatment therapy or disease progression.

The Cedara I-Response and Cedara PET/CT software products are line extensions to Cedara's medical image processing workstation product, Cedara I-SoftView™. The products are designed to facilitate the oncology or other clinical specialty workflow by comparing medical imaging data from different modalities and/or from different time points. The products are able to coregister functional MRI, PET, SPECT, CT, or other modality datasets. segment out Regions of Interest (ROI), and calculate, display, and report relative differences in Apparent Diffusion Coefficient (ADC). Standardized Update Value (SUV), or other values within those regions.

The products can be used as standalone applications or can be "plugged in" and launched from within other applications such as Cedara I-SoftView, or from another workstation or console.

The PROVIDED TEXT DOES NOT CONTAIN INFORMATION REGARDING THE ACCEPTANCE CRITERIA OR A STUDY DESIGNED TO PROVE THE DEVICE MEETS SUCH CRITERIA.

The document is a 510(k) summary for Cedara I-Response and Cedara PET/CT software, which describes the device, its intended use, and substantial equivalence to predicate devices. It also includes the FDA's clearance letter. However, it does not detail specific performance acceptance criteria or the results of a study demonstrating the device meets those criteria.

Therefore, I cannot provide the requested table and study information based on the provided text.

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