BEYONDIMAGE WORKSTATION— 510(k) K092235

Substantially Equivalent

Neusoft Medical Systems Co., Ltd.

FDA 510(k) clearance K092235 for BEYONDIMAGE WORKSTATION, Substantially Equivalent on 2009-08-06. Applicant: Neusoft Medical Systems Co., Ltd..

Clearance details

Applicant: Neusoft Medical Systems Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-07-23
Decision date: 2009-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, Liaoning, CN

Download summary PDF View on FDA.gov ↗

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.