NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0— 510(k) K080540

Substantially Equivalent

Neusoft Medical Systems Co., Ltd.

FDA 510(k) clearance K080540 for NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0, Substantially Equivalent on 2008-03-13. Applicant: Neusoft Medical Systems Co., Ltd..

Clearance details

Applicant: Neusoft Medical Systems Co., Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2008-02-27
Decision date: 2008-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, Liaoning, 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.