K110942

Substantially Equivalent

PICA WHOLE-BODY MRI SYSTEM

Applicant: Time Medical Limited
Product code: LNH
Advisory panel: Radiology
Date received: 2011-04-04
Decision date: 2011-07-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hong Kong, CN

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.