TomTec Imaging Systems received 510(k) clearance to market its new Cardio-Scan cardiac ultrasound image acquisition product. The company also won clearance for upgrades of its Sono-Scan 3-D add-on software and its Sono-Scan Pro computer system.
The Munich, Germany vendor said all three products are upgrades of earlier releases. Cardio-Scan is similar to Sono-Scan, but features gated acquisition and is optimized for cardiology. Sono-Scan, which was originally cleared a year ago, is an add-on device designed for acquisition, processing, and analysis of 3-D ultrasound images.
Although the 510(k) filing was primarily for the new product, Cardio-Scan, TomTec said it took the opportunity to refile the other products in the same family with new features and algorithms.
The prices of all three software packages are in the lower $20,000 range, and all are commercially available.
By AuntMinnie.com staff writersJune 27, 2002
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