K241572

ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)

510(k) number
K241572
Device name
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
Applicant
Siemens Medical Solutions USA, Inc. PA · US
Product code
OWB — Interventional Fluoroscopic X-Ray System
Decision date
2024-10-22
Date received
2024-05-31
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain

Also available from FDA: K241572.pdf

Official FDA record: K241572
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.