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Genius AI Detection 2.0 with CC-MLO Correlation
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230096
- 510(k) Type
- Traditional
- Applicant
- Hologic, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/23/2023
- Days to Decision
- 130 days
- Submission Type
- Summary