OMB Individually Reported
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
High riskExact public inventory row
Description
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, as well as displays the internal structure and/or function of the head, body, or extremities
Detailed example
Denoised images.
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
When interpreted by a trained physician, these images and/or spectra and the physical parameters derived from the images and/or spectra yield information that may assist in diagnosis.
Controls / human review
ATO: Not reported; PIA: Not published