FDA 510(k) Applications Submitted by HOLOGIC, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K102768 |
09/24/2010 |
SECRMARK BIOPSY SITE MARKING SYSTEM |
HOLOGIC, INC. |
| K041266 |
05/12/2004 |
PEDIATRIC REFERENCE DATABASE |
HOLOGIC, INC. |
| K200866 |
04/01/2020 |
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) |
Hologic, Inc. |
| K172629 |
09/01/2017 |
Panther Fusion AdV/hMPV/RV Assay |
Hologic, Inc. |
| K173901 |
12/22/2017 |
MyoSure MANUAL Tissue Removal Device |
Hologic, Inc. |
| K043617 |
11/26/2007 |
IMAGECHECKER CT CAD SOFTWARE SYSTEM |
HOLOGIC, INC. |
| K080711 |
03/13/2008 |
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION |
HOLOGIC, INC. |
| K072847 |
10/04/2007 |
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
| K172566 |
08/25/2017 |
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices |
Hologic, Inc. |
| K142037 |
07/28/2014 |
QUANTRA |
HOLOGIC, INC. |
| K120472 |
02/16/2012 |
QUANTRA |
HOLOGIC, INC. |
| K082483 |
08/28/2008 |
QUANTRA |
HOLOGIC, INC. |
| K103265 |
11/04/2010 |
NHANES WHOLE BODY DXA REFERENCE DATABASE |
HOLOGIC, INC. |
| K180825 |
03/30/2018 |
Fluent Fluid Management System |
Hologic, Inc. |
| K051025 |
04/22/2005 |
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
HOLOGIC, INC. |
| K121280 |
04/30/2012 |
MYOSURE INTRUMENT TRAY |
HOLOGIC, INC. |
| K032546 |
08/18/2003 |
HOLOGIC DR IMAGEPRO |
HOLOGIC, INC. |
| K042480 |
09/13/2004 |
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS |
HOLOGIC, INC. |
| K033224 |
10/06/2003 |
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER |
HOLOGIC, INC. |
| K230096 |
01/13/2023 |
Genius AI Detection 2.0 with CC-MLO Correlation |
Hologic, Inc. |
| K201019 |
04/17/2020 |
Genius AI Detection |
Hologic, Inc. |
| K221449 |
05/18/2022 |
Genius AI Detection 2.0 |
Hologic, Inc. |
| K111508 |
06/01/2011 |
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 |
HOLOGIC, INC. |
| K123873 |
12/17/2012 |
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY |
HOLOGIC, INC. |
| K002711 |
08/31/2000 |
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER |
HOLOGIC, INC. |
| K130277 |
02/04/2013 |
SINGLE ENERGY (SE) FEMUR EXAMS |
HOLOGIC, INC. |
| K120388 |
02/07/2012 |
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
HOLOGIC, INC. |
| K132316 |
07/25/2013 |
MULTIVIEW |
HOLOGIC, INC. |
| K113356 |
11/14/2011 |
HOLOGIC VISCERAL FAT SOFTWARE |
HOLOGIC, INC. |
| K963363 |
08/27/1996 |
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS |
HOLOGIC, INC. |
| K103512 |
11/30/2010 |
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
HOLOGIC, INC. |
| K100692 |
03/10/2010 |
DIGITAL SPOT MAMMOGRAPHY SYSTEM |
HOLOGIC, INC. |
| K040884 |
04/05/2004 |
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM |
HOLOGIC, INC. |
| K140960 |
04/15/2014 |
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
HOLOGIC, INC. |
| K062107 |
07/24/2006 |
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 |
HOLOGIC, INC. |
| K123530 |
11/16/2012 |
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) |
HOLOGIC, INC. |
| K103385 |
11/18/2010 |
SECURVIEW DX DIAGNOSTIC WORKSTATION |
HOLOGIC, INC. |
| K060111 |
01/17/2006 |
IVA (MXA II SOFTWARE OPTION) |
HOLOGIC, INC. |
| K061561 |
06/05/2006 |
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
| K190452 |
02/25/2019 |
Aptima BV Assay |
Hologic, Inc. |
| K190472 |
02/26/2019 |
Aptima CV/TV Assay |
Hologic, Inc. |
| K190515 |
03/01/2019 |
Aptima Combo 2 Assay (Panther System) |
Hologic, Inc. |
| K180681 |
03/15/2018 |
Aptima Combo 2 Assay (Panther System) |
Hologic, Inc. |
| K172282 |
07/28/2017 |
Panther Fusion Paraflu Assay |
Hologic, Inc. |
| DEN180047 |
08/31/2018 |
Aptima Mycoplasma genitalium Assay |
Hologic, Inc. |
| K091378 |
05/11/2009 |
MAMMOSITE II RADIATION THERAPY SYSTEM |
HOLOGIC, INC. |
| K092405 |
08/06/2009 |
MAMMOSITE MULTI LUMEN |
HOLOGIC, INC. |
| K220321 |
02/03/2022 |
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 |
Hologic, Inc. |
| K200436 |
02/24/2020 |
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 |
Hologic, Inc. |
| K231017 |
04/10/2023 |
Panther Fusion AdV/hMPV/RV Assay |
Hologic, Inc. |
| K190694 |
03/18/2019 |
Unifi Workspace v1.0.0 |
Hologic, Inc. |
| K182727 |
09/28/2018 |
Trident HD Specimen Radiography System |
Hologic, Inc. |
| K091368 |
05/08/2009 |
R2 DIGITALNOW HD(DIGITALNOW HD) |
HOLOGIC, INC. |
| K983028 |
08/31/1998 |
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W |
HOLOGIC, INC. |
| K992677 |
08/10/1999 |
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W |
HOLOGIC, INC. |
| K992775 |
08/18/1999 |
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W |
HOLOGIC, INC. |
| K974058 |
10/27/1997 |
FS IV MINI C-ARM SYSTEM |
HOLOGIC, INC. |
| K163623 |
12/22/2016 |
Quantra |
HOLOGIC, INC. |
| K961787 |
05/09/1996 |
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
| K191281 |
05/13/2019 |
Omni Hysteroscope, Omni Lok cervical seal |
Hologic, Inc. |
| K100943 |
04/06/2010 |
INVADER FACTOR II |
HOLOGIC, INC. |
| K100987 |
04/09/2010 |
INVADER MTHFR 677 |
HOLOGIC, INC. |
| K100496 |
02/22/2010 |
INVADER MTHFR 1298 |
HOLOGIC, INC. |
| K100980 |
04/08/2010 |
INVADER FACTOR V |
HOLOGIC, INC. |
| K081179 |
04/25/2008 |
MAMMOSITE CAVITY EVALUATION DEVICE |
HOLOGIC, INC. |
| K041555 |
06/10/2004 |
SECURVIEW DX SOFTCOPY WORKSTATION |
HOLOGIC, INC. |
| K023398 |
10/09/2002 |
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY |
HOLOGIC, INC. |
| K171963 |
06/30/2017 |
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes |
Hologic, Inc. |
| K162673 |
09/26/2016 |
Aptima Herpes Simplex Viruses 1 & 2 Assay |
HOLOGIC, INC. |
| K153219 |
11/05/2015 |
ProFlu+ Assay |
HOLOGIC, INC. |
| K153223 |
11/06/2015 |
ProParaFlu+ Assay |
HOLOGIC, INC. |
| K120593 |
02/28/2012 |
MYOSURE CONTROL UNIT |
HOLOGIC, INC. |
| K120947 |
03/29/2012 |
THS INSTRUMENT TRAY |
HOLOGIC, INC. |
| K131581 |
05/31/2013 |
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) |
HOLOGIC, INC. |
| K131736 |
06/13/2013 |
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) |
HOLOGIC, INC. |
| K121868 |
06/26/2012 |
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) |
HOLOGIC, INC. |
| K142029 |
07/25/2014 |
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
HOLOGIC, INC. |
| K122498 |
08/16/2012 |
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) |
HOLOGIC, INC. |
| K122563 |
08/22/2012 |
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL |
HOLOGIC, INC. |
| K163052 |
11/01/2016 |
Brevera Biopsy System with Corlumina Imaging Technology |
HOLOGIC, INC. |
| K222736 |
09/09/2022 |
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay |
Hologic, Inc. |
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