QYV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3900
- Medical specialty
- Pathology
- FDA definition
- The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology diagnosis.
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| Record | Firm | Date |
|---|---|---|
| “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” (DEN210035) | Hologic, Inc. | 2024-01-31 |
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