PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01— 510(k) K093984

Name: FDA 510(k) clearance K093984
Creator: U.S. Food and Drug Administration
Published: 2010-03-24

Substantially Equivalent

Time Medical Limited

FDA 510(k) clearance K093984 for PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01, Substantially Equivalent on 2010-03-24. 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: 2009-12-24
Decision date: 2010-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, 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.