AI-Rad Companion (Pulmonary)— 510(k) K213713

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K213713 for AI-Rad Companion (Pulmonary), Substantially Equivalent on 2022-08-11. Applicant: Siemens Healthcare GmbH.

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: Code JAK
Advisory panel: Radiology
Date received: 2021-11-24
Decision date: 2022-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, 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.