TomTec receives FDA 510(k) clearance for its new Image-Com 5.0 software


TomTec Imaging Systems has announced the FDA 510(k) clearance for its new Image-Com 5 software solution. 

The Image-Com 5.0 combines 2D and 3D imaging in one single viewer. A company release says: “The Image-Com 5.0 provides access to the entire TomTec cardiology and radiology application portfolio to analyse even proprietary data formats such as Philips, GE, Siemens and Toshiba.”

“Time efficient image-review, measurements and analysis plays a growingly important role in improving the quality of patient care,” said Alex Kirn, product manager at TomTec Imaging Systems. “Image-Com has been developed to speed up workflow in the daily routine. It automatically imports measurements from the modalities such as ultrasound, provides labeled echocardiography and vascular measurements and exports the results to the electronic patient record.”

“We are very excited about the introduction and timely US market clearance of this new product as it helps obstetrician/gynecologist and cardiologists to optimise their workflow towards clinical outcome and efficiency,” said Gregor Malischnig, TomTec’s Business Unit Manager Healthcare IT.

TomTec will present the new Image-Com at the upcoming Radiological Society of North America (RSNA) meeting in Chicago.