510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210035Unknown

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

Hologic, Inc., Malborough MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210035 is the FDA 510(k) clearance record for “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”, a class II device, cleared for Hologic, Inc. on under FDA product code QYV (Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm). FDA's definition for product code QYV reads: "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...". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming DEN210035.

Clearance record

Decision date
Received
(887 days to decision)
Product code
QYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Regulation
21 CFR 864.3900
Device class
Class II
Review panel
Pathology
Applicant
Hologic, Inc. 250 Campus Dr., Malborough MA
Third party review
No

Clearances, product code QYV

Trailing 12 months

FDA records hold no clearances under product code QYV in the trailing twelve months.

FDA records show no clearances under product code QYV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260