Device Dossier
Workstation, picture archiving and communication system
Device Dossier for Workstation, picture archiving and communication system (Workstation, picture archiving and communication system, Class IIb, sponsor…
- GMDN category: Workstation, picture archiving and communication system
Intended purpose
Ashvins is a modular software solution and is used for viewing, reporting, processing, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information. Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM “For Presentation” images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed. Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants