A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and f...
An assembly of devices specifically designed to provide a fixed installation (in an imaging facility, or transportation van) x-ray system to compress and image the breast. It is primarily used to optimize the capability of users to visually evaluate x-ray f...
A stationary specimen x-ray system designed for permanent fixture in one location to generate and control x-ray beams and to record the absorption patterns of x-rays passing through tissue samples (e.g., stereotactic biopsy cores taken during mammographic p...
An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption pattern...
An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption pattern...
A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ or organ system...
An interpretive software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology or microbiology laboratory to assist in the analysis of clinical specimens (e.g., biopsy, blood smear, urin...
A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of a patient’s breast using cone beam computed tomography (CBCT); it may be intended to assist a breast biops...
A software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology laboratory to assist in the analysis of stained or unstained clinical specimens (e.g., biopsy, cytology or blood smear on...