New Carestream Premium General Diagnostic Ultrasound Systems Receive FDA Clearance

Two new ultrasound systems designed for general diagnostic imaging use, have received US Food and Drug Administration (FDA) 510(k) clearance.

The systems feature advanced imaging capabilities, and a sealed touch control panel. The panel has etched markings for primary controls to help clinicians locate key functions using tactile feedback, without having to look at the panel, during imaging exams.


The Carestream (Rochester, NY, USA) Touch Prime, and Touch Prime XE systems use the SynTek Architecture, which optimizes image formation, reduces noise and artifacts, and can visualize moving structures. The Touch Prime XE can achieve frame rates greater than 100 Hz, and includes optional support for Digital Imaging and Communications in Medicine (DICOM), wireless connectivity, elastography, and badge and barcode readers. The system also features imaging and Doppler improvements.

Both systems were designed mindful of feedback from ultrasound users, and include a sealed panel for easy cleaning, are lightweight, use “Swipe and go” secure badge access for logging-on, one-touch selection of the desired transducer, and a rapid boot time.

Diana L. Nole, president of Digital Medical Solutions in Carestream, said, “These new ultrasound systems build upon our proven expertise in digital X-ray systems. 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 extremely high image quality.”

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