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TomTec Imaging obtains FDA 510(k) clearance for TomTec-Arena 1.0 software

Germany-based TomTec Imaging Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its TomTec-Arena 1.0 software solution.

TomTec-Arena 1.0 is the newest addition to the company’s product portfolio.

TomTec’s 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, angio, magnetic resonance and nuclear.

It combines the company’s entire cardiology and radiology application portfolio in one product.

The TomTec-Arena can analyze standard 2D Digital Imaging and Communications in Medicine (DICOM) as well as 2D and 3D proprietary data formats such as from Philips, General Electric Company, Siemens and Toshiba.

TomTec Imaging Systems president and CMO Bernhard Mumm noted time efficient image review, measurements and analysis plays a very important role to improve the clinical workflow.

"TomTec-Arena has been developed to be integrated into our PACS partner systems as well as into our Image-Arena platform," Mumm added.

TomTec will present its solutions for radiology and cardiology ultrasound and the new TomTec-Arena package at the RSNA meeting in Chicago.