OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4— 510(k) K092899

Substantially Equivalent

Ningbo Xingaoyi Magnetism Co., Ltd.

FDA 510(k) clearance K092899 for OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4, Substantially Equivalent on 2009-11-10. Applicant: Ningbo Xingaoyi Magnetism Co., Ltd..

Clearance details

Applicant: Ningbo Xingaoyi Magnetism Co., Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2009-09-21
Decision date: 2009-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuyao, Zhejiang, CN

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.