SYNGO INSPACE 4D— 510(k) K043469

Substantially Equivalent

Siemens AG Medical Solutions

FDA 510(k) clearance K043469 for SYNGO INSPACE 4D, Substantially Equivalent on 2005-02-03. Applicant: Siemens AG Medical Solutions.

Clearance details

Applicant: Siemens AG Medical Solutions
Product code: Code JAK
Advisory panel: Radiology
Date received: 2004-12-16
Decision date: 2005-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Forchheim, Bavaria, 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.