syngo.CT Cardiac Planning— 510(k) K170221

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K170221 for syngo.CT Cardiac Planning, Substantially Equivalent on 2017-04-21. Applicant: Siemens Healthcare GmbH.

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: Code JAK
Advisory panel: Radiology
Date received: 2017-01-25
Decision date: 2017-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Forchheim, DE

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.