Philips wins FDA 510(k) for small parts ultrasound transducer

Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its eL18-4 ultrasound transducer designed for ‘small parts’ assessments to detect abnormalities in small organs close to the skin. The Amsterdam-based company said the device is part of its Ultimate Small Parts Solution which also features the company’s MicroFlow Imaging, Elastography and Precision Biopsy technology. The eL18-4 transducer is also designed to assess musculoskeletal injuries. “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,” ultrasound biz lead Vitor Rocha said in a prepared statement. Philip touted the clearance as a first for a device designed specifically to assess diseases and disorders of small organs such as breasts, testicles and thyroid and to assess musculoskeletal injuries including sprains and tears. “My clinical experience with the new Philips eL18-4 small parts transducer has enabled excellent versatility and penetration that could easily replace my current transducers. I am able to see subtle lesions with great detail and excellent sensitivity for ...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance royalphilips Source Type: news