DeviceClearance

K251650

Substantially Equivalent

Insight Enhanced™ DRF (EN-1002-01)

Applicant
Imaging Engineering, LLC
Product code
JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gainesville, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA
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.