SCANNER, COMPUTERIZED TOMOGRAPHIC— 510(k) K803181

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K803181 for SCANNER, COMPUTERIZED TOMOGRAPHIC, Substantially Equivalent on 1981-01-28. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code JAK
Advisory panel: Radiology
Date received: 1980-12-16
Decision date: 1981-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.