TomTec nets FDA OK for new 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.

Tom-Tec Arena is a suite of clinical applications designed to review, analyze, and quantify medical image data in 2D and 3D/4D, as well as from multiple modalities, such as ultrasound, x-ray, MRI, and nuclear medicine.

The software combines TomTec's entire cardiology and radiology application portfolio in one product, with the ability to analyze standard 2D DICOM and 2D and 3D proprietary data formats from all major ultrasound vendors.

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