Device Description
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.