ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION— 510(k) K923077

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K923077 for ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION, Substantially Equivalent on 1993-02-02. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code JAK
Advisory panel: Radiology
Date received: 1992-06-25
Decision date: 1993-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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.