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Genius AI Detection 2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221449
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/6/2022
Days to Decision
141 days
Submission Type
Summary

Genius AI Detection 2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221449
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/6/2022
Days to Decision
141 days
Submission Type
Summary