DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM— 510(k) K883072

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K883072 for DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM, Substantially Equivalent on 1988-09-14. Applicant: Siemens Gammasonics, Inc..

Clearance details

Applicant: Siemens Gammasonics, Inc.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1988-07-20
Decision date: 1988-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.