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www.fdanews.com/articles/171463-carestream-healths-ultrasound-systems-secure-fda-510k-clearance

Carestream Health’s Ultrasound Systems Secure FDA 510(k) Clearance

June 2, 2015

Carestream Health announced Tuesday that its Touch Prime ultrasound system and Touch Prime XE ultrasound system are available for order in the U.S., following receipt of FDA 510(k) clearance. The systems have been indicated for radiology diagnostic imaging.

The products are the company’s first ultrasound systems and feature a sealed panel to enable easy cleaning for pathogens.

Additionally, the Touch Prime XE features SynTek Architecture, which uses technology to enhance spatial detail with higher frame rates to improve moving structure visuals.

The company plans a European launch following pending CE Mark approval.

Carestream offers dental and medical imaging systems and IT products, X-ray imaging systems and advanced materials for the precisions films and electronics market. — Jason Scott