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Royal Philips gets FDA 510(k) clearance for small parts ultrasound imaging solution

MDBR Staff Writer Published 16 October 2017

Health technology firm Royal Philips has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new small parts ultrasound imaging solution.

Philips EPIQ Ultimate Small Parts Solution has been approved to detect abnormalities in the small organs, which are close to the skin.

Available on Philips EPIQ 7 and 5 and Affiniti 70 ultrasound systems, the new solution will be showcased at the 16th World Federation for Ultrasound in Medicine and Biology (WFUMB) Congress in Taipei.

Philips EPIQ Ultimate Small Parts Solution includes four new features, comprising of eL18-4 PureWave linear array transducer, Philips microFlow imaging, Philips elastography and Philips precision biopsy.

Philips eL18-4 transducer helps to deliver detail resolution and tissue uniformity for clinical solutions, comprising of thyroid, breast, testicular, musculoskeletal, vascular, bowel, pediatrics and obstetrics.

The new eL18-4 transducer will also help to evaluate musculoskeletal injuries.

The MicroFlow Imaging offers better sensitivity and detail for small vessel blood flow assessment, while complete Elastography solution with both strain and ElastQ Imaging capability offers definitive information on tissue stiffness.

Philip new precision biopsy capabilities allow to minimize needle blind zones and support the ability to enhance the display of needle reflections.

Philips ultrasound business leader Vitor Rocha said: “The superb image quality derived from Philips’ breakthrough, ultra-broadband frequency transducer along with full solution Elastography support, helps clinicians make confident clinical decisions driven by an exam that is easier to perform.

“With the new Philips Ultimate Small Parts Solution, clinicians now have the power to comprehensively assess and treat small parts and deliver better care for their patients with all-in-one functionality.”  


Image: The new Philips eL18-4 PureWave linear array transducer will deliver detail resolution and tissue uniformity for clinical solutions. Photo: courtesy of Koninklijke Philips N.V.