Hologic, Inc.
FDA 510(k) medical device clearances.
Top product codes for Hologic, Inc.
Recent clearances by Hologic, Inc.
1–100 of 116- K253634 — CoolSeal Generator® (CSL-200-90)
- K251993 — Panther Fusion GI Expanded Bacterial Assay
- K243341 — Genius AI Detection 2.0
- K243396 — Aptima SARS-CoV-2 Assay
- K243935 — Aptima CMV Quant Assay
- K243345 — Aptima BV Assay; Aptima CV/TV Assay
- K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
- K240886 — 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)
- K233352 — Aptima HCV Quant Dx Assay
- K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- DEN210035 — Genius Digital Diagnostics System with the Genius Cervical AI algorithm
- K231329 — Aptima Neisseria gonorrhoeae Assay
- K230451 — Aptima® Chlamydia trachomatis Assay
- K231316 — Aptima Trichomonas vaginalis Assay
- K230096 — Genius AI Detection 2.0 with CC-MLO Correlation
- K222736 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- K231017 — Panther Fusion AdV/hMPV/RV Assay
- K221449 — Genius AI Detection 2.0
- K220321 — 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
- K201019 — Genius AI Detection
- K202294 — Affirm Contrast Biopsy
- K200866 — Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
- K200436 — 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
- K191281 — Omni Hysteroscope, Omni Lok cervical seal
- K190694 — Unifi Workspace v1.0.0
- K190452 — Aptima BV Assay
- K190515 — Aptima Combo 2 Assay (Panther System)
- K190472 — Aptima CV/TV Assay
- K182052 — Omni Instrument Tray
- DEN180047 — Aptima Mycoplasma genitalium Assay
- K182727 — Trident HD Specimen Radiography System
- K182006 — Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
- K181974 — MyoSure XL Tissue Removal Device for Fluent
- K180825 — Fluent Fluid Management System
- K180681 — Aptima Combo 2 Assay (Panther System)
- K173901 — MyoSure MANUAL Tissue Removal Device
- K180233 — Eviva Stereotactic Guided Breast Biopsy System
- K172629 — Panther Fusion AdV/hMPV/RV Assay
- K172282 — Panther Fusion Paraflu Assay
- K163623 — Quantra
- K171963 — Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
- K172566 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay
- K163052 — Brevera Biopsy System with Corlumina Imaging Technology
- K153486 — Affirm Prone Biopsy System
- K153223 — ProParaFlu+ Assay
- K153219 — ProFlu+ Assay
- K152723 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K150169 — Sertera Biopsy Device
- K142029 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K142037 — QUANTRA
- K140960 — PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K132316 — MULTIVIEW
- K131581 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
- K131736 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
- K130277 — SINGLE ENERGY (SE) FEMUR EXAMS
- K121280 — MYOSURE INTRUMENT TRAY
- K123873 — CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
- K123530 — MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
- K120947 — THS INSTRUMENT TRAY
- K122563 — MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
- K122498 — MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
- K121868 — MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
- K120472 — QUANTRA
- K120388 — INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- K120593 — MYOSURE CONTROL UNIT
- K113356 — HOLOGIC VISCERAL FAT SOFTWARE
- K111508 — TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
- K100943 — INVADER FACTOR II
- K100980 — INVADER FACTOR V
- K100987 — INVADER MTHFR 677
- K100496 — INVADER MTHFR 1298
- K103265 — NHANES WHOLE BODY DXA REFERENCE DATABASE
- K103385 — SECURVIEW DX DIAGNOSTIC WORKSTATION
- K103512 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
- K102768 — SECRMARK BIOPSY SITE MARKING SYSTEM
- K100692 — DIGITAL SPOT MAMMOGRAPHY SYSTEM
- K092405 — MAMMOSITE MULTI LUMEN
- K091378 — MAMMOSITE II RADIATION THERAPY SYSTEM
- K091368 — R2 DIGITALNOW HD(DIGITALNOW HD)
- K082483 — QUANTRA
- K080711 — 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
- K081179 — MAMMOSITE CAVITY EVALUATION DEVICE
- K072847 — APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
- K043617 — IMAGECHECKER CT CAD SOFTWARE SYSTEM
- K062107 — SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
- K061561 — HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
- K060111 — IVA (MXA II SOFTWARE OPTION)
- K051025 — FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- K042480 — INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
- K041266 — PEDIATRIC REFERENCE DATABASE
- K041555 — SECURVIEW DX SOFTCOPY WORKSTATION
- K040884 — LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
- K033224 — HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
- K032546 — HOLOGIC DR IMAGEPRO
- K023398 — HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
- K002711 — HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
- K992775 — OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K992677 — EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K983028 — FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
Data sourced from openFDA. This site is unofficial and independent of the FDA.