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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital cervical cytology slide imaging system with artificial intelligence algorithm
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.
Product CodeQYV
Regulation Number 864.3900
Device Class 2


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Instructions for Healthcare Professional 2 2
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Hologic, Inc II Apr-24-2026
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