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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Genius Digital Diagnostics System with the Genius Cervical AI algorithm
Classification Name: DIGITAL CERVICAL CYTOLOGY SLIDE IMAGING SYSTEM WITH ARTIFICIAL INTELLIGENCE ALGORITHM
Product Code: QYV
Device Class: 2
Regulation Number: 864.3900
Medical Specialty: Pathology
Registered Establishment Name: HOLOGIC, INC.
Registered Establishment Number: 1222780
Premarket Submission Number: DEN210035
Owner/Operator: HOLOGIC, INC.
Owner/Operator Number: 9007676
Establishment Operations: Manufacturer; Specification Developer
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