DeviceClearance

K901848

Substantially Equivalent

GADOLINIUM-153 BONE DENSITOMETER SOURCES

Applicant
Amersham Corp.
Product code
KGI
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arlington Heights, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KGI

product code KGI
Other
1
Total
1

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.