DeviceClearance

K230096

Substantially Equivalent

Genius AI Detection 2.0 with CC-MLO Correlation

Applicant
Hologic, Inc.
Product code
QDQ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlborough, MA, US
Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.