Konica Minolta Direct Digitizer Regius Sigma System - HSA Registration DE0011616
Access comprehensive regulatory information for Konica Minolta Direct Digitizer Regius Sigma System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011616 and owned by Konica Minolta, Inc.. The device was registered on November 16, 2012.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
This device reads exposed X-ray image data saved to a plate within a cassette, then outputs it as diagnosis image data to the connected console. In order to operate this device, a medical image processing workstation called the ImagePilot is required as a console. The ImagePilot is sold separately. Additionally, the cassette and plate dedicated to this device must be used. General X-ray images are the intended diagnostic images of this device. Mammographic images are not included.