SOMATOM On.site— 510(k) K241295

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K241295 for SOMATOM On.site, Substantially Equivalent on 2024-09-03. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2024-05-08
Decision date: 2024-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.