Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005496266

FEI Number

3005496266

Entity Name

HOLOGIC, INC.

City/State/Country

Newark, DE, US

Establishment Address

600 Technology Drive, Newark, DE 19702, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

HOLOGIC, INC. (Owner Number: 9007676)

Owner / Operator Contact Address

250 Campus Drive, --, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082432

PMA Number

N/A

All Registered Proprietary Names

Genius AI Detection 2 APEX 2 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS Selenia Dimensions Mammography System Affirm Breast Biopsy Guidance System Affirm Prone Biopsy System Unifi Workspace Horizon DXA System FAXITRON SPECIEN RADIOGRAPHY SYSTEM Quantra Faxitron PathPlus Specimen Radiography System Genius AI Detection IMAGECHECKER CT CAD SOFTWARE SYSTEM Affirm Lateral Arm Upright Biopsy Accessory MAMMOPAD RADIOLUCENT CUSHION digital image communications, radiological MODIFIED 650 MAMMOGRAPHY SYSTEM SELENIA DIMENSIONS 3D SYSTEM & ACCESSORIES 3Dimensions System & Accessories Genius 3D Mammography Dimensions Access System Hologic 3D mammogram AFFIRM BREAST BIOPSY GUIDANCE SYSTEM ImageChecker CAD MODIFIED M-IV MAMMOGRAPHY SYSTEM Affirm® Contrast Biopsy R2 DIGITALNOW HD(DIGITALNOW HD) Brevera Breast Biopsy System with Corlumina Imaging Technology QUANTRA MULTICARE PLATINUM SYSTEM AND ACCESSORIES SecurView DX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Faxitron Core Specimen Radiography System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2026-01-07
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2015-10-20
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2007-11-30
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2013-09-03
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2016-04-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-07-12
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2013-08-02
MWP	Cabinet, X-Ray System	Radiology	Class 2	892.1680	2021-07-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-01-15
MWP	Cabinet, X-Ray System	Radiology	Class 2	892.1680	2021-07-15
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2021-01-22
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2024-03-07
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2016-08-11
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2013-09-11
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2013-09-11
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2005-08-19
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2005-08-19
OTE	Digital Breast Tomosynthesis	Unknown	Class 3	N/A	2011-11-08
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2011-11-08
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2007-02-28
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2005-08-19
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2021-07-09
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2021-07-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-01-10
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-04-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-10-31
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2005-08-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-11-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-01-23
MWP	Cabinet, X-Ray System	Radiology	Class 2	892.1680	2020-10-07

Official Correspondent

Sue Dahlquist

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HOLOGIC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013649990	HEALTH BEACONS, INC.	Marlborough, MA, US
3012644426	ENDOMAGNETICS LTD	Cambridge Cambridgeshire, GB
3005875675	GYNESONICS, INC.	REDWOOD CITY, CA, US
3006330030	Hologic, Inc.	Marlborough, MA, US
3010377594	BOLDER SURGICAL, LLC	LOUISVILLE, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K983273	Medical Systems, Inc.	XCT 2000 L PQCT BONE DENSITOMETER	1998-10-29
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005496266. Last updated year: 2026. Please use registration number 3005496266 when referencing this establishment in official correspondence.