K183388

Substantially Equivalent

JADE Mobile X-Ray

Applicant
DRGEM Corporation
Product code
IZL
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gwangmyeong-Si, KR
Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL
Other
3
Total
3

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.