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

MUNICH--(BUSINESS WIRE)--TomTec Imaging Systems GmbH announces the FDA 510(k) clearance for its new Image-Com 5 software solution.

“We are very excited about the introduction and timely US market clearance of this new product as it helps obstetrician/gynecologist and cardiologists to optimize their workflow towards clinical outcome and efficiency.”

The Image-Com 5.0 software is the newest addition to TomTec’s Image-Arena image management solution. Driven by more than 20 years of experience in 2D and 3D/4D image review, TomTec succeeded to combine 2D and 3D imaging uniquely in one single viewer. It provides access to the entire TomTec cardiology and radiology application portfolio to analyze 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”, says 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.

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

Image-Com 5.0 offers multimodality, multidimensional, multivendor image review and access to one of the most comprehensive sets of clinical applications.

TomTec will present the new Image-Com at the upcoming RSNA meeting in Chicago. Visit TomTec at the RSNA 2012 Hall B North Building #8608.

About TomTec:

For more than 20 years TomTec Imaging Systems GmbH, with headquarters located in Munich, Germany holds an inventive leadership position in the field of diagnostic medical imaging applications and Cardio PACS solutions. The company maintains close working relationships with many leading universities and device manufacturers around the world.

TomTec’s product portfolio encompasses a wide range of 2D and 3D/4D technologies for visualization, analysis, reporting and archiving of multimodality imaging data. TomTec solutions are applicable in the fields of Adult- and Pediatric Cardiology as well as Obstetrics, Gynecology, Radiology, and Vascular Imaging. Visit TomTec's web site at www.tomtec.de