TomTec gets FDA clearance for imaging software

Imaging software developer TomTec Imaging Systems has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TomTec-Arena software.

TomTec-Arena is a suite of clinical applications to review, analyze, and quantify medical image data in multiple dimensions (2D and 3D/4D), as well as from multiple modalities such as ultrasound, angiography, MR, and nuclear medicine, TomTec said.

TomTec-Arena combines the company's entire cardiology and radiology application portfolio in one product; it can analyze standard 2D DICOM as well as 2D and 3D data formats, according to the company.

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