510(k) DEN210035

Genius Digital Diagnostics System with the Genius Cervical AI algorithm by Hologic, Inc. — Product Code QYV

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: January 31, 2024
Date Received: August 27, 2021
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Device Class: Class II
Regulation Number: 864.3900
Review Panel: PA
Submission Type

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.

Other clearances by Hologic, Inc.

K251868 — Panther Fusion GI Bacterial Assay (September 25, 2025)
K251993 — Panther Fusion GI Expanded Bacterial Assay (September 25, 2025)
K243341 — Genius AI Detection 2.0 (July 31, 2025)
K243396 — Aptima SARS-CoV-2 Assay (February 13, 2025)
K243935 — Aptima CMV Quant Assay (January 17, 2025)
K243345 — Aptima BV Assay; Aptima CV/TV Assay (November 25, 2024)
K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (November 15, 2024)
K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 2024)
K233352 — Aptima HCV Quant Dx Assay (July 24, 2024)
K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (July 18, 2024)