Genius AI Detection— 510(k) K201019
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K201019 for Genius AI Detection, Substantially Equivalent on 2020-11-18. Applicant: Hologic, Inc..
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code QDQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malborough, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.