BEYONDIMAGE WORKSTATION— 510(k) K102435

Substantially Equivalent

Neusoft Medical Systems Co., Ltd.

FDA 510(k) clearance K102435 for BEYONDIMAGE WORKSTATION, Substantially Equivalent on 2010-10-15. Applicant: Neusoft Medical Systems Co., Ltd..

Clearance details

Applicant: Neusoft Medical Systems Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-08-26
Decision date: 2010-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, Liaoning, CN

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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.