SYNGO NEURO DSA CT— 510(k) K053024

Substantially Equivalent

Siemens AG

FDA 510(k) clearance K053024 for SYNGO NEURO DSA CT, Substantially Equivalent on 2005-11-04. Applicant: Siemens AG.

Clearance details

Applicant: Siemens AG
Product code: Code JAK
Advisory panel: Radiology
Date received: 2005-10-21
Decision date: 2005-11-04
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.