Medical Device Manufacturer · US , Waltham , MA

Hologic, Inc.

115 submissions · 111 cleared · Since 1987
115
Total
111
Cleared
2
Denied

Hologic, Inc. — FDA 510(k) Submissions

Hologic, Inc. has submitted 115 FDA 510(k) premarket notifications since 1987, of which 111 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Densitometer, Bone, System, Image Processing, Radiological, Hysteroscope (and Accessories), Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections, System, X-ray, Mammographic . Use the specialty filter in the sidebar to narrow results.

115 devices
1–25 of 115
Panther Fusion GI Expanded Bacterial Assay
K251993 · PCH Gastrointestinal Pathogen... · Microbiology
Sep 2025 90d
Genius AI Detection 2.0
K243341 · QDQ Radiological Computer... · Radiology
Jul 2025 279d
Aptima SARS-CoV-2 Assay
K243396 · QQX Respiratory Specimen... · Microbiology
Feb 2025 105d
Aptima CMV Quant Assay
K243935 · PAB Cytomegalovirus (cmv) Dna... · Microbiology
Jan 2025 28d
Aptima BV Assay; Aptima CV/TV Assay
K243345 · PQA Vaginitis And Bacterial... · Microbiology
Nov 2024 28d
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K242465 · QOF Multi-target Respiratory... · Microbiology
Nov 2024 87d
Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
K240886 · HIG Insufflator, Hysteroscopic · Obstetrics & Gynecology
Jul 2024 115d
Aptima HCV Quant Dx Assay
K233352 · MZP Assay, Hybridization... · Microbiology
Jul 2024 299d
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · QOF Multi-target Respiratory... · Microbiology
Jul 2024 76d
?Genius? Digital Diagnostics System with the Genius? Cervical AI algorithm?
DEN210035 · QYV Digital Cervical Cytology... · Pathology
Jan 2024 887d
Aptima Neisseria gonorrhoeae Assay
K231329 · LSL Dna-reagents, Neisseria · Microbiology
Jan 2024 263d
Aptima? Chlamydia trachomatis Assay
K230451 · MKZ Dna Probe, Nucleic Acid... · Microbiology
Nov 2023 268d
Aptima Trichomonas vaginalis Assay
K231316 · OUY Trichomonas Vaginalis... · Microbiology
Nov 2023 182d
Genius AI Detection 2.0 with CC-MLO Correlation
K230096 · QDQ Radiological Computer... · Radiology
May 2023 130d
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K222736 · QOF Multi-target Respiratory... · Microbiology
May 2023 249d
Panther Fusion AdV/hMPV/RV Assay
K231017 · OCC Respiratory Virus Panel... · Microbiology
May 2023 25d
Genius AI Detection 2.0
K221449 · QDQ Radiological Computer... · Radiology
Oct 2022 141d
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
K220321 · QEP Nucleic Acid Detection... · Microbiology
Jun 2022 120d
Genius AI Detection
K201019 · QDQ Radiological Computer... · Radiology
Nov 2020 215d
Affirm Contrast Biopsy
K202294 · IZH System, X-ray, Mammographic · Radiology
Oct 2020 53d
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
K200866 · QEP Nucleic Acid Detection... · Microbiology
May 2020 46d
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
K200436 · QEP Nucleic Acid Detection... · Microbiology
Mar 2020 28d
Omni Hysteroscope, Omni Lok cervical seal
K191281 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Aug 2019 108d
Unifi Workspace v1.0.0
K190694 · LLZ System, Image Processing,... · Radiology
Jul 2019 115d
Aptima BV Assay
K190452 · PQA Vaginitis And Bacterial... · Microbiology
May 2019 87d

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