Two Carestream Health Ultrasound Systems Receive FDA 510(k) Clearance

Carestream Health Inc. is introducing two new ultrasound systems to the U.S. market, having recently received U.S. Food and Drug Administration 510(k) clearance for the products.

Both the Carestream Touch Prime Ultrasound System and Carestream Touch Prime XE Ultrasound System are designed for general diagnostic imaging use in radiology, company executives said in a news release. The two products are the first in Carestream’s new family of ultrasound systems, which feature an all-touch control panel and advanced imaging capabilities.

“These new ultrasound systems build upon our expertise in digital X-ray systems,” said Diana L. Nole, president of Digital Medical Solutions for Carestream. “We started with a clean slate and worked with customers to develop a new generation of ultrasound systems that enhance ease of use and productivity, while incorporating integrated GPU processing power that delivers fast response times and high image quality.”

The Carestream Touch Prime XE is being touted as the company’s top-of-the-line offering. It employs Carestream’s Touch Prime SynTek Architecture, which is a combination of breakthrough technologies that simultaneously provide enhanced spatial detail with increased frame rates for improved visualization of moving structures while optimizing image formation to reduce noise and artifacts. Imaging and Doppler improvements allow for more consistent visualization of subtle tissue contrast differences and can improve the ability to see small structures.

The Touch Prime XE, meanwhile, is capable of frame rates in excess of 100Hz while maintaining improved imaging detail, and includes optional features such as DICOM, wireless connectivity, barcode and badge readers and elastography as part of the system, Carestream bigwigs noted.

Both the Touch Prime and Touch Prime XE offer a sealed, all-touch control panel that combines the speed and flexibility of a soft user interface with the tactile feedback of traditional keys. Etched marking for primary controls assists the user with easily locating key functions without looking away from the image display monitor.

Both Touch Ultrasound systems deliver the following capabilities:


• A sealed panel allows for easy cleaning to help limit the spread of pathogens;
• High-level computing power which provides both speed and good image quality;
• Easy maneuverability and a small, lightweight footprint to make the imaging process faster and easier;
• A “swipe and go” badge log-on that reportedly saves time and promotes secure access;
• “Smart connect” transducer technology that enables one-touch selection of the desired transducer;
• Rapid cold boot time of 18 seconds, which can help enhance productivity, with no need for standby mode or battery backup; and
• Cart adjustments to allow sonographers to position the system where it is most comfortable to help reduce the risk of repetitive stress injuries.


The design team for Carestream’s family of Touch Ultrasound systems gathered input from ultrasound professionals around the world to select and refine the capabilities of this new platform, the company said.

Carestream’s Touch Prime and Touch Prime XE are expected to ship in the fourth quarter of 2015.

Carestream is a worldwide provider of dental and medical imaging systems and IT solutions; X-ray imaging systems for non-destructive testing; and advanced materials for the precision films and electronics markets. The company is based in Rochester, N.Y.