Digirad (DRAD) Receives 510(k) Clearance from FDA for Cardius X-ACT Rapid Cardiac SPECT/VCT Imager

March 26, 2009 7:52 AM EDT

Digirad Corporation (Nasdaq: DRAD) today announced that it has received 510(k) clearance from the US FDA, enabling the Company to market and manufacture its Cardius(R) X-ACT imaging system.

Cardius X-ACT is a rapid cardiac SPECT/VCT imaging system that features a low-dose volume-computed tomography (VCT) attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues increasing interpretive ease and accuracy. The revolutionary X-ACT approach takes advantage of the full 24-inch wide detector array eliminating truncation and generating high-precision transmission maps improving the overall quality of SPECT studies. The X-ACT attenuation correction system offers high accuracy, fast acquisition, low dose (5 uSv / study) and superb reliability. The system's high-speed triple-head solid-state design combined with nSPEED(R) software allows the combined cardiac SPECT emission and transmission acquisitions to be performed in as little as five minutes. The Cardius X-ACT system increases diagnostic confidence in nuclear cardiology and raises the standard in the industry for overall SPECT system performance.

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