MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Siemens Medical Solutions USA, Inc. · K231560 · 2023-10-23

MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit is an AI-enabled medical device from Siemens Medical Solutions USA, Inc., listed by FDA (510(k), K231560) with a decision date of 2023-10-23. Review panel: Radiology.

FDA submission numberK231560
Pathway510(k)
CompanySiemens Medical Solutions USA, Inc.
Review panel (specialty)Radiology
FDA decision date2023-10-23
DecisionSubstantially Equivalent
Product codeLNH
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Device class2
Regulation number892.1000
Review time (calendar days)146
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

More devices from Siemens Medical Solutions USA, Inc. · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.