510(k) K230096
- Device
- Genius AI Detection 2.0 with CC-MLO Correlation
- Applicant
- Hologic, Inc.
- 510(k) number
- K230096
- Product code
- QDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-23
- Date received
- 2023-01-13
- Regulation
- 892.2090
- Classification name
- Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Deborah Thomas
- Address
- 250 Campus Dr. Marlborough MA US 01730 01730
FDA Registration Numbers
- 3016819165
- 3026970882
- 3021230777
- 3025343020
- 3015173173
- 3030412475
- 3023522713
- 3018733944
- 3016759115
- 3005496266
- 3042248552
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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