EMMA 1.5T MRI System— 510(k) K183621

Name: FDA 510(k) clearance K183621
Creator: U.S. Food and Drug Administration
Published: 2019-02-22

Substantially Equivalent

Time Medical Limited

FDA 510(k) clearance K183621 for EMMA 1.5T MRI System, Substantially Equivalent on 2019-02-22. Applicant: Time Medical Limited. Device class: 2.

Clearance details

Applicant: Time Medical Limited
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2018-12-26
Decision date: 2019-02-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shatin, Nt, Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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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.