3D-ANGIO— 510(k) K984634

Substantially Equivalent

Siemens Medical Corp.

FDA 510(k) clearance K984634 for 3D-ANGIO, Substantially Equivalent on 1999-03-12. Applicant: Siemens Medical Corp..

Clearance details

Applicant: Siemens Medical Corp.
Product code: Code JAK
Advisory panel: Radiology
Date received: 1998-12-30
Decision date: 1999-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iselin, NJ, US

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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.