K233650

SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed

510(k) number
K233650
Device name
SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
Applicant
Siemens Medical Solutions USA, Inc. TN · US
Product code
JAK — System, X-Ray, Tomography, Computed
Decision date
2024-03-26
Date received
2023-11-14
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
510(k) Summary (official FDA PDF): K233650.pdf
Official FDA record: K233650
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.