DIRA KRC detector gets FDA clearance
27.05.2011
DIRA announces that it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for its digital x-ray CCD based detector. With this clearance the company is now authorized to market the detector in the USA.
Getting FDA approval means that DIRA product meets the highest requirements, manufacturing quality and safety standards. This is a very important step for DIRA ensuring the success in achieving its main goal which is to deliver high quality and efficient solutions for medical imaging.
DIRA KRC detector is designed for use in any diagnostic imaging system and it is suitable for a range of applications. The clinical benefits in medical application are lower radiation dose to the patient combined with excellent image quality.
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