DeviceClearance

K251822

Substantially Equivalent

MAGNETOM Free.Max; MAGNETOM Free.Star

Applicant
Siemens Shenzhen Magnetic Resonance , Ltd.
Product code
LNH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen, 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, through . 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.