Pathology · De Novo · 2024
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
Hologic Inc.. Granted by FDA on 31 January 2024 under submission DEN210035, product code QYV (digital cervical cytology slide imaging system with artificial intelligence algorithm). What FDA's record says, in FDA's words.
Device record · DEN210035
- Device. Genius Digital Diagnostics System with the Genius Cervical AI algorithmDEVICE
- Company. Hologic Inc.COMPANY
- Decision. 31 January 2024, De NovoDECISION
- Panel. PathologyPANEL
- Product code. QYV, Digital Cervical Cytology Slide Imaging System With Artificial Intelligence AlgorithmCODE
- Regulation. 21 CFR 864.3900, Class IIREG
- Source. FDA database entry · decision document (36 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
below. B Indication(s) for Use: The GeniusTM Digital Diagnostics System with the GeniusTM Cervical AI algorithm includes the GeniusTM Digital Imager, GeniusTM Image Management Server (IMS), the GeniusTM Review Station, and the GeniusTM Cervical AI algorithm. The GeniusTM Digital Diagnostics System with the GeniusTM Cervical Al algorithm is intended for the creation and viewing of digital images of scanned ThinPrepe Pap Test glass slides. Objects of interest selected by the GeniusTM Cervical AI algorithm from the scanned digital image are presented in a gallery format next to the image of the whole cell spot on the GeniusTm Review Station for review and interpretation. The Genius Digital Diagnostics System with the GeniusTM Cervical AI algorithm is intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions) and carcinoma, as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical Cytology'. After digital review with the Genius Cervical Al algorithm, if there is uncertainty in the diagnosis, then direct examination of the glass slide by light microscopy should be performed. Digital images from the Genius Digital Diagnostics System with the GeniusTM Cervical Al algorithm should be interpreted by qualified cytologists and pathologists in conjunction with the patient's […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedpathology slides
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5 reports filed against devices carrying product code QYV. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
6 July 2026 · Malfunction · GENIUS IMAGER · HOLOGIC, INC. · report 1222780-2026-00397
A CUSTOMER REPORTED A POTENTIAL DISCREPANT CASE FOUND ON THE DIGITAL DIAGNOSTICS SYSTEM. NO DELAY IN PATIENT DIAGNOSIS OCCURRED. INTERNAL INVESTIGATION IS ONGOING AND RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
17 June 2026 · Malfunction · GENIUS DIGITAL DIAGNOSITC SYSTEM · HOLOGIC, INC. · report 1222780-2026-00393
THE CUSTOMER REPORTED A SLIDE MIX MATCH ON THE DIGITAL DIAGNOSTICS SYSTEM. HOLOGIC TROUBLESHOOTING BETWEEN CYTOTECHNOLOGISTS AND FIELD SERVICE ENGINEER CONFIRMED THAT THE IMAGE WAS ASSOCIATED WITH AN INCORRECT SLIDE ACCESSION ID. INCORRECT ACCESSION ID PRESENTS A RISK OF PATIENT SAMPLE MISIDENTIFICATION AND POTENTIAL MISDIAGNOSIS.
26 May 2026 · Malfunction · GENIUS DIGITAL DIAGNOSTICS SYSTEM · HOLOGIC, INC. · report 1222780-2026-00332
CUSTOMER REPORTED A DISCREPANCY IN DIAGNOSIS DURING A COMPARISON BETWEEN SYSTEMS AT THE SITE. THE CASE WAS INTERPRETED AS NEGATIVE ON THE GENIUS¿ DIGITAL DIAGNOSTICS SYSTEM AND POSITIVE ON THE IMAGER SYSTEM BY CYTOSCREENERS AND PATHOLOGISTS. NO DELAY IN PATIENT DIAGNOSIS OCCURRED. INTERNAL INVESTIGATION IS ONGOING AND RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
28 April 2026 · Malfunction · GENIUS¿ DIGITAL DIAGNOSTICS SYSTEM · HOLOGIC, INC. · report 1222780-2026-00185
THE CUSTOMER REPORTED THAT THE MACRO IMAGE FOR THE REPORTED CASE WAS A MISMATCH ON THE GENIUS DIGITAL DIAGNOSTICS SYSTEM. HOLOGIC TROUBLESHOOTING BETWEEN CYTOTECHNOLOGISTS AND FIELD SERVICE ENGINEER CONFIRMED THAT THE IMAGE WAS ASSOCIATED WITH AN INCORRECT SLIDE ACCESSION ID. INCORRECT ACCESSION ID PRESENTS A RISK OF PATIENT SAMPLE MISIDENTIFICATION AND POTENTIAL MISDIAGNOSIS.
6 April 2026 · Malfunction · GENIUS REVIEW STATION MONITOR · HOLOGIC, INC. · report MW5186395
HOLOGIC IS NOTIFYING YOU OF A POTENTIAL DISPLAY ISSUE THAT CAN OCCUR ON THE GENIUS TM DIGITAL DIAGNOSTICS SYSTEM IF THE DISPLAY SETTINGS ON THE GENIUS TM REVIEW STATION MONITOR (HOLOGIC PART NUMBER (B)(4) HAVE BEEN CHANGED FROM THE ORIGINAL CONFIGURATION. UPON RECEIPT OF THIS LETTER, YOU ARE REQUIRED TO PROMPTLY COMPLETE THE ONLINE CUSTOMER RESPONSE FORM (CRF). COMPLETION OF THE CRF IS REQUIRED TO SUPPORT HOLOGIC'S FIELD CORRECTION. HOLOGIC HAS IDENTIFIED THAT DISPLAY PERFORMANCE OF THE […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QYV, in Pathology, from Hologic Inc., or granted in 2024. The whole record is at FDA AI-enabled medical devices.
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