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Hologic

Diagnostics makerAI in United StatesAI. FDA records under 9 spellings of its name, each linked to the record.

  • Records across the group: 538, 17 entitiesAI
  • 510(k) clearances: 478
  • Device recalls: 50
  • AI-enabled devices: 9
  • Warning letters: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Hologic and its 16 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Sep 2, 2026I-View®K254090 · MUE510(k) clearances
Aug 12, 2026Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)K262792 · KNW510(k) clearances
Jun 17, 2026PICOSURE WORKSTATIONK261570 · GEX510(k) clearances
Jun 17, 2026CoolSeal Generator® (CSL-200-90)K253634 · GEI510(k) clearances
Sep 25, 2025Panther Fusion GI Expanded Bacterial AssayK251993 · PCH510(k) clearances
Sep 25, 2025Panther Fusion GI Bacterial AssayK251868 · PCH510(k) clearances
Jul 31, 2025Genius AI Detection 2.0K243341 · QDQ510(k) clearances
Jul 31, 2025Genius AI Detection 2.0K243341 · RadiologyAI-enabled devices
Feb 13, 2025Aptima SARS-CoV-2 AssayK243396 · QQX510(k) clearances
Dec 18, 2024Warning letter: Sterility assurance, CAPA, MDR reportingCDRHWarning letters
Jan 31, 2024“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”DEN210035 · PathologyAI-enabled devices
May 23, 2023Genius AI Detection 2.0 with CC-MLO CorrelationK230096 · RadiologyAI-enabled devices
Oct 6, 2022Genius AI Detection 2.0K221449 · RadiologyAI-enabled devices
Nov 18, 2020Genius AI DetectionK201019 · RadiologyAI-enabled devices
Oct 20, 2017QuantraK163623 · RadiologyAI-enabled devices
Oct 10, 2014QUANTRAK142037 · RadiologyAI-enabled devices
Apr 17, 2014APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen ColleClass III · Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box oDevice recalls
Sep 12, 2008QUANTRAK082483 · RadiologyAI-enabled devices

Subsidiaries and Divisions

16 firms in the Hologic group, most records first

Canada and Imports

Across the Hologic group, matched by company name
Active Health Canada device licences
118, as of Nov 10, 2026
FDA import refusals since 2024
3 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
Hologic, Inc.Hologic, IncHOLOGIC, INC.HologicHologic IncHologic Inc.
FEI numbers in warning letters
1000120743

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.