DIGITRON STENOSIS PROTOCOL— 510(k) K881481

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K881481 for DIGITRON STENOSIS PROTOCOL, Substantially Equivalent on 1988-10-12. Applicant: Siemens Gammasonics, Inc..

Clearance details

Applicant: Siemens Gammasonics, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1988-04-08
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.