Company · US
Hologic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2026. Name variants (Inc, Corp, punctuation) are merged.
120510(k) clearances (3 in 12 months)
63recalls (6 in 12 months)
38recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KGI | Densitometer, Bone | 40 |
| LLZ | System, Image Processing, Radiological | 14 |
| HIH | Hysteroscope (And Accessories) | 13 |
| KNW | Instrument, Biopsy | 11 |
| IZH | System, X-Ray, Mammographic | 7 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 7 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 7 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 5 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 5 |
| NEU | Marker, Radiographic, Implantable | 4 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 4 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 4 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 4 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 |
| OTE | Digital Breast Tomosynthesis | 3 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 3 |
| GDF | Guide, Needle, Surgical | 2 |
| HIG | Insufflator, Hysteroscopic | 2 |
| LKV | Enzyme Immunoassay, Fetal Fibronectin | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2026 | K254090 | I-View® Hologic, Inc. | MUE |
| Aug 12, 2026 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) Hologic, Inc. | KNW |
| Jun 17, 2026 | K253634 | CoolSeal Generator® (CSL-200-90) Hologic, Inc. | GEI |
| Sep 25, 2025 | K251993 | Panther Fusion GI Expanded Bacterial Assay Hologic, Inc. | PCH |
| Sep 25, 2025 | K251868 | Panther Fusion GI Bacterial Assay Hologic | PCH |
| Jul 31, 2025 | K243341 | Genius AI Detection 2.0 Hologic, Inc. | QDQ |
| Feb 13, 2025 | K243396 | Aptima SARS-CoV-2 Assay Hologic, Inc. | QQX |
| Jan 17, 2025 | K243935 | Aptima CMV Quant Assay Hologic, Inc. | PAB |
| Nov 25, 2024 | K243345 | Aptima BV Assay; Aptima CV/TV Assay Hologic, Inc. | PQA |
| Nov 15, 2024 | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay Hologic, Inc. | QOF |
| Jul 25, 2024 | K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT- Hologic, Inc. | HIG |
| Jul 24, 2024 | K233352 | Aptima HCV Quant Dx Assay Hologic, Inc. | MZP |
| Jul 18, 2024 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Hologic, Inc. | QOF |
| Jan 31, 2024 | DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm Hologic, Inc. | QYV |
| Jan 26, 2024 | K231329 | Aptima Neisseria gonorrhoeae Assay Hologic, Inc. | LSL |
| Nov 16, 2023 | K230451 | Aptima® Chlamydia trachomatis Assay Hologic, Inc. | MKZ |
| Nov 6, 2023 | K231316 | Aptima Trichomonas vaginalis Assay Hologic, Inc. | OUY |
| May 23, 2023 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation Hologic, Inc. | QDQ |
| May 16, 2023 | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Hologic, Inc. | QOF |
| May 5, 2023 | K231017 | Panther Fusion AdV/hMPV/RV Assay Hologic, Inc. | OCC |
| Oct 6, 2022 | K221449 | Genius AI Detection 2.0 Hologic, Inc. | QDQ |
| Jun 3, 2022 | K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis As Hologic, Inc. | QEP |
| Nov 18, 2020 | K201019 | Genius AI Detection Hologic, Inc. | QDQ |
| Oct 5, 2020 | K202294 | Affirm Contrast Biopsy Hologic, Inc. | IZH |
| May 17, 2020 | K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) Hologic, Inc. | QEP |
| Mar 23, 2020 | K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginali Hologic, Inc. | QEP |
| Aug 29, 2019 | K191281 | Omni Hysteroscope, Omni Lok cervical seal Hologic, Inc. | HIH |
| Jul 11, 2019 | K190694 | Unifi Workspace v1.0.0 Hologic, Inc. | LLZ |
| May 23, 2019 | K190515 | Aptima Combo 2 Assay (Panther System) Hologic, Inc. | QEP |
| May 23, 2019 | K190452 | Aptima BV Assay Hologic, Inc. | PQA |
| May 16, 2019 | K190472 | Aptima CV/TV Assay Hologic, Inc. | PQA |
| Feb 26, 2019 | K182052 | Omni Instrument Tray Hologic, Inc. | KCT |
| Jan 23, 2019 | DEN180047 | Aptima Mycoplasma genitalium Assay Hologic, Inc. | QEP |
| Jan 10, 2019 | K182727 | Trident HD Specimen Radiography System Hologic, Inc. | MWP |
| Dec 6, 2018 | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths Hologic, Inc. | HIH |
| Aug 23, 2018 | K181974 | MyoSure XL Tissue Removal Device for Fluent Hologic, Inc. | HIH |
| Aug 3, 2018 | K180825 | Fluent Fluid Management System Hologic, Inc. | HIG |
| Jun 13, 2018 | K180681 | Aptima Combo 2 Assay (Panther System) Hologic, Inc. | LSL |
| May 8, 2018 | K173901 | MyoSure MANUAL Tissue Removal Device Hologic, Inc. | HIH |
| Apr 10, 2018 | K180233 | Eviva Stereotactic Guided Breast Biopsy System Hologic, Inc. | KNW |
| Dec 4, 2017 | K172629 | Panther Fusion AdV/hMPV/RV Assay Hologic, Inc. | OCC |
| Oct 23, 2017 | K172282 | Panther Fusion Paraflu Assay Hologic, Inc. | OOU |
| Oct 20, 2017 | K163623 | Quantra Hologic, Inc. | LLZ |
| Sep 26, 2017 | K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusi Hologic, Inc. | OCC |
| Sep 20, 2017 | K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Hologic, Inc. | HIH |
| Jun 15, 2017 | K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay Hologic, Inc. | OQO |
| Mar 29, 2017 | K163052 | Brevera Biopsy System with Corlumina Imaging Technology Hologic, Inc. | KNW |
| Aug 10, 2016 | K161575 | Affirm Lateral Arm Upright Biopsy Accessory Hologic | IZH |
| Apr 1, 2016 | K153486 | Affirm Prone Biopsy System Hologic, Inc. | IZH |
| Dec 9, 2015 | K153223 | ProParaFlu+ Assay Hologic, Inc. | OOU |
Newest 50 of 120.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Hologic, Inc 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-N Open, Classified |
OTE | None listed |
| May 12, 2026 | Hologic, Inc SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, Open, Classified |
MUE | None listed |
| Apr 24, 2026 | Hologic, Inc Brand Name: Genius" Review Station
Product Name: Genius" Review Station Display (Barco Monitor)
Model/Catalog Number: CMP-01669
Software Version: N/A - not software version specific
Component: Yes, th Open, Classified |
QYV | None listed |
| Mar 19, 2026 | Hologic, Inc. Brand Name: Aptima HPV Assay
Product Name: Aptima HPV Assay
Model/Catalog Number: 303585
Product Description: Aptima HPV assay
Component: No Open, Classified |
OYB | None listed |
| Feb 6, 2026 | Hologic, Inc Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. Open, Classified |
KNW | K163052 |
| Jan 15, 2026 | Hologic, Inc ThinPrep CytoLyt Solution. Buffered Cell Wash Solution. Open, Classified |
LEA | None listed |
| Feb 13, 2025 | Hologic, Inc Brand Name: Sertera Biopsy Device
Product Name: Sertera Biopsy Device
Model/Catalog Number: Sertera-14
Software Version: N/A
Product Description: Instrument, Biopsy
Component: N/A Open, Classified |
KNW | K150169 |
| Feb 4, 2025 | Hologic, Inc. The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party sup Open, Classified |
LIO | K900225 |
| Jan 14, 2025 | Hologic, Inc. Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. Open, Classified |
NJR | K181156 |
| Dec 20, 2024 | Hologic, Inc. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 Open, Classified |
QOF | K222736 |
| Dec 11, 2024 | Hologic, Inc Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide
Model/Catalog Number: F0101 Completed |
FZX | None listed |
| Nov 26, 2024 | Hologic, Inc BioZorb Marker. Radiographic soft tissue marker. Open, Classified |
NEU | K143484 K152070 |
| Sep 25, 2024 | Hologic Inc Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis
Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows
Model/Catalog Number:
1. ASY-16824 FMI UPGRADE KIT, DIM Open, Classified |
OTE | None listed |
| Jul 16, 2024 | Hologic Inc Horizon X-Ray Bone Densitometer (DXA)
Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN Open, Classified |
KGI | K023398 |
| May 3, 2024 | Hologic, Inc BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue.
1) F0405 BioZorb Marker 4cm x 5cm
2) F0404 BioZorb Marker 4cm x 4cm
3) F0331 BioZorb Marker 1c Open, Classified |
NEU | K152070 |
| Mar 22, 2024 | Hologic, Inc. Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstit Open, Classified |
PAB | None listed |
| Jan 23, 2024 | Hologic, Inc. PANTHER FUSION System REF 9121010000
The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through Open, Classified |
OOI | None listed |
| Jun 29, 2023 | Hologic, Inc Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast
REF: SERTERA-14 Open, Classified |
KNW | K150169 |
| Feb 21, 2023 | Hologic, Inc. Hologic 3Dimensions/Selenia Dimensions
Models:
RM-SDM-00001-3D
SDM-00001-2D
SDM-00001-3D
SDM-05000-3D3
SDM-05000-2DC
SDM-00001-M3D
SDM-05000-3DC
SDM-SYS-6000-3D
SDM-05000-2D3
SDA-SYS-3000-2D
SDM-0000 Open, Classified |
OTE | None listed |
| Sep 30, 2022 | Hologic, Inc The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component Open, Classified |
NEU | K152070 |
| Apr 6, 2022 | Hologic, Inc Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. Open, Classified |
NJR | K181156 |
| Jan 27, 2022 | Hologic, Inc Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Open, Classified |
JTW | None listed |
| Feb 26, 2021 | Hologic, Inc Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the Open, Classified |
NSU | None listed |
| Aug 4, 2020 | Hologic, Inc Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 Terminated |
NSU | None listed |
| Feb 18, 2020 | Hologic, Inc. Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636, Terminated |
MUE | None listed |
| Oct 10, 2019 | Hologic, Inc Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium H Open, Classified |
OCC | K171963 |
| Dec 6, 2018 | Hologic, Inc. I-View Contrast Enhanced Digital Mammography, ASY-08109 Terminated |
MUE | K123873 |
| Jan 20, 2018 | Hologic, Inc Hologic Panther(R) Fusion(TM), Catalog number ASY-09600
Product Usage:
The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates Terminated |
NSU | K132251 |
| Nov 29, 2017 | Hologic, Inc. Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q Terminated |
LKV | None listed |
| Nov 29, 2017 | Hologic, Inc. Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 Terminated |
LKV | None listed |
| Sep 15, 2017 | Hologic, Inc Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use Terminated |
NSU | K132251 |
| Jul 7, 2017 | Hologic, Inc. Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 Terminated |
OIJ | K161575 |
| Jun 27, 2017 | Hologic, Inc Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument. Terminated |
JQW | None listed |
| Nov 22, 2016 | Hologic, Inc SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices.
SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices.
For uterine sound Terminated |
HHM | None listed |
| Sep 21, 2016 | Hologic, Inc Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. Terminated |
KNW | K150169 |
| Sep 8, 2016 | Hologic, Inc SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece
Product Usage:
The Sure Sight Obturato Terminated |
GDF | None listed |
| Sep 8, 2016 | Hologic, Inc SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece) Terminated |
GDF | None listed |
| Jul 19, 2016 | Hologic, Inc ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy. Terminated |
KDQ | None listed |
| Mar 31, 2016 | Hologic, Inc Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. Terminated |
NUA | K063787 |
| Mar 31, 2016 | Hologic, Inc CF InPlex ASR Card; Catalog Number: 95-0501. Terminated |
NUA | None listed |
| Jun 3, 2014 | Hologic, Inc. Hologic M-IV Mammography System; Model M4--00001.
Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast. Terminated |
IZH | K011987 |
| Jun 3, 2014 | Hologic, Inc. Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039.
The Selenia Full Field Digital Mammography system generates digital mammography images that can be u Terminated |
MUE | None listed |
| Feb 26, 2014 | Hologic, Inc NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001
Catalog Number: RFC2009
Product Usage: The NovaSure Impedance Controlled Endometrial Abl Terminated |
MNB | None listed |
| Sep 30, 2013 | Hologic, Inc. Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x
The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screen Terminated |
MUE | None listed |
| May 17, 2013 | Hologic, Inc. Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2
The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization o Terminated |
JAA | K051025 |
| May 17, 2013 | Hologic, Inc. Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x
The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patien Terminated |
JAA | K051025 |
| Sep 25, 2012 | Hologic, Inc. Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2
The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic v Terminated |
JAA | K051025 |
| Sep 25, 2012 | Hologic, Inc. Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1
The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic vis Terminated |
JAA | K051025 |
| Apr 5, 2012 | Hologic, Inc. Hologics SecurView DX workstation, software version 7.3.0
intended for viewing mammography images and other imaging modalities.
SecurView DX is intended for selection, display, manipulation, filing Terminated |
LLZ | K103385 |
| Aug 12, 2011 | Hologic, Inc. Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate
The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The Terminated |
JAA | K843920 |
Newest 50 of 63.