510(k) K230096 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Genius AI Detection 2.0 with CC-MLO Correlation
| Applicant | Hologic, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, May 23, 2023 |
| Received | Jan 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230096
No recall in the FDA data names this 510(k).
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