HeartIT Receives FDA 510(k) Clearance for Wider Clinical Indications
August 17, 2016 – Heart Imaging Technologies,LLC (HeartIT) today announced that the United States Food and Drug Administration (FDA) has issued a new 510(k) clearance for HeartIT’s products, FDA 510(k) Number K152949. The new clearance states that HeartIT’s software products “can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR).”
The expanded indication also provides for the ability to “post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.”
The new FDA clearance includes HeartIT’s flagship product, WebPAX, as well as its Precession product, which focuses on cardiovascular magnetic resonance imaging (CMR).
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About Heart IT
Founded in 2000 and headquartered near North Carolina’s Research Triangle Park, Heart IT is a global leader in the medical image web enablement field. Heart Imaging Technologies was the first company to offer a FDA approved zero foot-print medical image workstation which has become the precedent for other companies seeking FDA approval. HeartIT provides web-based medical image management technology and services to health care systems, large hospitals and private clinics as well as drug and device companies sponsoring multi-center clinical trials. Worldwide, Heart Imaging Technologies solutions provide secure web browser access to over one billion medical images. For more information visit our website at www.heartit.com.