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Data / Medical devices / United States / Hologic, Inc.

Hologic, Inc.: FDA-registered device maker in Newark, DE, United States, 35 510(k) clearances and 3 PMA approvals

Hologic, Inc. is registered with the FDA (registration 3005496266) in Newark, DE, United States. It lists 15 device types. The FDA files 35 510(k) clearances and 3 PMA approvals under its listings, the newest dated July 31, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Hologic, Inc.
FDA registration number
3005496266
Address
600 Technology Drive, Newark, DE, United States, 19702
Owner or operator
HOLOGIC, INC. (9007676)
Roles
Complaint file establishment, Manufacturer, Remanufacturer, Specification developer
First device listed
August 19, 2005
Registered through
2027
Brand names listed
3Dimensions System & Accessories, AFFIRM BREAST BIOPSY GUIDANCE SYSTEM, APEX 2 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS, Affirm Breast Biopsy Guidance System, Affirm Lateral Arm Upright Biopsy Accessory, Affirm Prone Biopsy System, Affirm® Contrast Biopsy, BIOLUCENT MAMMOGRAPHY CUSHION and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Medical ImageMYN2Manufactureraccessdata.fda.gov
Cabinet, X-Ray SystemMWP2Complaint file establishment, Manufacturer, Remanufactureraccessdata.fda.gov
Camera, Scintillation (Gamma)IYX1Complaint file establishment, Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishment, Specification developeraccessdata.fda.gov
Densitometer, BoneKGI2Complaint file establishment, Manufacturer, Remanufactureraccessdata.fda.gov
Digital Breast TomosynthesisOTE3Complaint file establishment, Manufactureraccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Complaint file establishment, Manufactureraccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, BiopsyKNW2Manufactureraccessdata.fda.gov
Lung Computed Tomography System, Computer-Aided DetectionOEB2Complaint file establishment, Manufactureraccessdata.fda.gov
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerQDQ2Complaint file establishment, Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Complaint file establishment, Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, MammographicIZH2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 31, 2025K243341Genius AI Detection 2.0QDQSubstantially EquivalentHologic, Inc.accessdata.fda.gov
May 23, 2023K230096Genius AI Detection 2.0 with CC-MLO CorrelationQDQSubstantially EquivalentHologic, Inc.accessdata.fda.gov
October 6, 2022K221449Genius AI Detection 2.0QDQSubstantially EquivalentHologic, Inc.accessdata.fda.gov
November 18, 2020K201019Genius AI DetectionQDQSubstantially EquivalentHologic, Inc.accessdata.fda.gov
October 5, 2020K202294Affirm Contrast BiopsyIZHSubstantially EquivalentHologic, Inc.accessdata.fda.gov
July 11, 2019K190694Unifi Workspace v1.0.0LLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
March 14, 2019K183142PathVisionXLMWPSubstantially EquivalentFaxitron Bioptics, LLCaccessdata.fda.gov
January 10, 2019K182727Trident HD Specimen Radiography SystemMWPSubstantially EquivalentHologic, Inc.accessdata.fda.gov
October 20, 2017K163623QuantraLLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
March 29, 2017K163052Brevera Biopsy System with Corlumina Imaging TechnologyKNWSubstantially EquivalentHologic, Inc.accessdata.fda.gov
August 10, 2016K161575Affirm Lateral Arm Upright Biopsy AccessoryIZHSubstantially EquivalentHologicaccessdata.fda.gov
April 1, 2016K153486Affirm Prone Biopsy SystemIZHSubstantially EquivalentHologic, Inc.accessdata.fda.gov
June 13, 2014K140960PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMLLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
October 30, 2013K132316MULTIVIEWLLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
January 29, 2013K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHYMUESubstantially EquivalentHologic, Inc.accessdata.fda.gov
January 11, 2013K122836AFFIRM BREAST BIOPSY GUIDANCE SYSTEMIZHSubstantially EquivalentLorad, A Hologic Co.accessdata.fda.gov
September 25, 2012K122428FAXITRON SPECIEN RADIOGRAPHY SYSTEMMWPSubstantially EquivalentFaxitron Bioptics, LLCaccessdata.fda.gov
June 22, 2012K120472QUANTRALLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
April 6, 2012K120388INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEMOXOSubstantially EquivalentHologic, Inc.accessdata.fda.gov
August 19, 2011K111508TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001MWPSubstantially EquivalentHologic, Inc.accessdata.fda.gov
February 2, 2011K103385SECURVIEW DX DIAGNOSTIC WORKSTATIONLLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
January 7, 2011K103512AFFIRM BREAST BIOPSY GUIDANCE SYSTEMIZHSubstantially EquivalentHologic, Inc.accessdata.fda.gov
April 6, 2010K100692DIGITAL SPOT MAMMOGRAPHY SYSTEMIZHSubstantially EquivalentHologic, Inc.accessdata.fda.gov
June 4, 2009K091368R2 DIGITALNOW HD(DIGITALNOW HD)LLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
November 21, 2008K082432CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEMMWPSubstantially EquivalentBioptics, Inc.accessdata.fda.gov
March 28, 2008K072847APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERSKGISubstantially EquivalentHologic, Inc.accessdata.fda.gov
December 21, 2007K043617IMAGECHECKER CT CAD SOFTWARE SYSTEMOEBSubstantially EquivalentHologic, Inc.accessdata.fda.gov
July 5, 2007K071542DIGITAL STEREOLOC IIIZHSubstantially EquivalentLorad, A Hologic Co.accessdata.fda.gov
September 13, 2006K062141MAMMOPAD RADIOLUCENT CUSHIONIYXSubstantially EquivalentBiolucent, Inc.accessdata.fda.gov
May 13, 2005K051025FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEMJAASubstantially EquivalentHologic, Inc.accessdata.fda.gov
March 25, 2003K030666MULTICARE PLATINUM SYSTEM AND ACCESSORIESIZHSubstantially EquivalentLorad, A Hologic Co.accessdata.fda.gov
November 8, 2002K023398HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERYKGISubstantially EquivalentHologic, Inc.accessdata.fda.gov
October 24, 2001K013290MODIFIED 650 MAMMOGRAPHY SYSTEMIZHSubstantially EquivalentLorad, A Hologic Co.accessdata.fda.gov
July 11, 2001K011987MODIFIED M-IV MAMMOGRAPHY SYSTEMIZHSubstantially EquivalentLorad, A Hologic Co.accessdata.fda.gov
February 14, 2001K003795BIOLUCENT MAMMOGRAPHY CUSHIONIZHSubstantially EquivalentBiolucent, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 11, 2011P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE10November 24, 2025accessdata.fda.gov
March 15, 2002P010025LORAD DIGITAL BREAST IMAGERMUE17November 16, 2010accessdata.fda.gov
June 26, 1998P970058M1000 IMAGECHECKERMYN26April 26, 2016accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 19, 202495286Class IIOngoingSelenia 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, DIMENSIONS 1.12.0.3 SYSIdentified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosisaccessdata.fda.gov
June 13, 202494905Class IIOngoingHorizon 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-CNNon-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.accessdata.fda.gov

Compare with other makers

Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.