OPTIMA CT520— 510(k) K123596

Substantially Equivalent

Ge Hangwei Medical Systems Co., Ltd.

FDA 510(k) clearance K123596 for OPTIMA CT520, Substantially Equivalent on 2013-02-08. Applicant: Ge Hangwei Medical Systems Co., Ltd..

Clearance details

Applicant: Ge Hangwei Medical Systems Co., Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2012-11-21
Decision date: 2013-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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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.