# Hologic, Inc.

- Location (FDA's records): Malborough, MA
- FDA decisions: 138 (1987–2026): 118 510(k) clearances, 2 De Novo grants and 18 original PMA approvals
- Names in FDA's records: Hologic, Inc. (136); Hologic (2)
- Product codes: KGI (29), LLZ (13), HIH (13), IZH (6), QEP (5), OCC (4), KNW (4), QDQ (4), MUE (4), PQA (3), KCT (3), JAQ (3)
- 510(k) review time since 2016: median 104 days, against 107 for FDA's reviews in the same codes and years (14 of 35 faster)
- Predicates its devices cite: 149 (66 its own); citations of its devices by later devices: 124 (66 its own)
- Recalls linked to its devices: 44 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gen-Probe, Inc.: 8 (https://510kreport.com/company/gen-probe)
- Biofire Diagnostics, LLC: 8 (https://510kreport.com/company/biofire-diagnostics)
- Interlace Medical, Inc.: 6 (https://510kreport.com/company/interlace-medical)
- Lorad, A Hologic Co.: 5 (https://510kreport.com/company/lorad-a-hologic)
- Proxima Therapeutics, Inc.: 4 (https://510kreport.com/company/proxima-therapeutics)
- Suros Surgical Systems, Inc.: 3 (https://510kreport.com/company/suros-surgical-systems)
- Lunar Corp.: 3 (https://510kreport.com/company/lunar)
- Sectra-Imtec AB: 2 (https://510kreport.com/company/sectra-imtec)

## Firms that cite its devices most
- Stryker Sustainability Solutions: 3 (https://510kreport.com/company/stryker-sustainability-solutions)
- Roche Molecular Systems, Inc.: 3 (https://510kreport.com/company/roche-molecular-systems)
- Abbott Molecular, Inc.: 3 (https://510kreport.com/company/abbott-molecular)
- Kub Technologies, Inc.: 3 (https://510kreport.com/company/kub-technologies)
- Mindways Software, Inc.: 2 (https://510kreport.com/company/mindways-software)
- Lorad, A Hologic Co.: 2 (https://510kreport.com/company/lorad-a-hologic)
- Cianna Medical, Inc.: 1 (https://510kreport.com/company/cianna-medical)
- Ge Medical Systems Ultrasound & Primary Care Diagn: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-primary-care-diagn)

## Its most-cited devices
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001 (2011), cited by 6
- K943505: Hologic QDR-3000 X-Ray Bone Densitometer (1995), cited by 5
- K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery (2002), cited by 5
- K983028: Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (1998), cited by 4
- K103385: Securview DX Diagnostic Workstation (2011), cited by 4
- DEN180047: Aptima Mycoplasma genitalium Assay (2019), cited by 4

## Recent decisions
- K254090: I-View® (Sep 2, 2026)
- K262792: Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) (Aug 12, 2026)
- K253634: CoolSeal Generator® (CSL-200-90) (Jun 17, 2026)
- K251868: Panther Fusion GI Bacterial Assay (Sep 25, 2025)
- K251993: Panther Fusion GI Expanded Bacterial Assay (Sep 25, 2025)
- K243341: Genius AI Detection 2.0 (Jul 31, 2025)
- K243396: Aptima SARS-CoV-2 Assay (Feb 13, 2025)
- K243935: Aptima CMV Quant Assay (Jan 17, 2025)

Source page: https://510kreport.com/company/hologic