DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE— 510(k) K861429

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K861429 for DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE, Substantially Equivalent on 1986-07-25. Applicant: Siemens Gammasonics, Inc..

Clearance details

Applicant: Siemens Gammasonics, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1986-04-16
Decision date: 1986-07-25
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.