NEONA 1.5T MRI System— 510(k) K222259

Substantially Equivalent

Time Medical Limited

FDA 510(k) clearance K222259 for NEONA 1.5T MRI System, Substantially Equivalent on 2023-02-21. Applicant: Time Medical Limited.

Clearance details

Applicant: Time Medical Limited
Product code: Code LNH
Advisory panel: Radiology
Date received: 2022-07-28
Decision date: 2023-02-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shatin, Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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.