HOLOGIC INC

3DIMENSIONS · Radiology

510(k): 0 Recall: 3 UDI: 23 MAUDE: 10 Class.: 60

Recalls (3)

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-NS.

2026-04-08

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

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, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSION

2024-08-19

Identified 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 diagnosis

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-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-

2023-01-16

C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

UDI Registrations (23)

3Dimensions

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions

Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.

3Dimensions™

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions™

Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.

3Dimensions

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

3Dimensions

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions

Intelligent 2D™ is a software feature where a high-resolution digital mammography image is generated from data acquired during a high-resolution breast tomosynthesis scan. The high resolution tomosynthesis image and the Intelligent 2D image have a pixel resolution of 70 microns.

3Dimensions™

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast. The Digital Breast Tomosynthesis imaging uses high-resolution Tomosynthesis, known as Clarity HD.

3Dimensions™

Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.

3Dimensions

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions™

3Dimensions

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions™

3Dimensions

Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.

3Dimensions™

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions™

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

3Dimensions

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

3Dimensions

Hologic Clarity HD® (high resolution tomosynthesis) is a software driven digital breast tomosynthesis 3(D) imaging feature intended to improve image resolution on tomosynhesis slices and synthesized 2D images that will enhance image quality and user experience.

3Dimensions

Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.

MAUDE Adverse Events (10)

Malfunction

20220210

Malfunction

20220110

Malfunction

20220110

Injury

20211203

Malfunction

20211029

Malfunction

20211026

Malfunction

20210803

Malfunction

20210715

Malfunction

20210421

Injury

20200625

FDA Classification (60)

Processor, Cine Film

Radiology

Hydrogel Spacer

Radiology

Cassette, Measurement, Ardran-Crooks

Radiology

Assembly, Tube Housing, X-Ray, Therapeutic

Radiology

Generator, Orthovoltage, Therapeutic X-Ray

Radiology

Cabinet, X-Ray System

Radiology

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Radiology

Camera, Multi Format, Radiological

Radiology

System, Imaging, Holography, Acoustic

Radiology

Film, Radiographic

Radiology

Counter, Whole Body, Nuclear

Radiology

Holder, Syringe, Lead

Radiology

Processor, Radiographic-Film, Automatic, Dental

Radiology

Camera, X-Ray, Fluorographic, Cine Or Spot

Radiology

System, Therapeutic, X-Ray

Radiology

Display, Diagnostic Radiology

Radiology

Radiation Therapy Marking Device

Radiology

Radiological Computer-Assisted Prioritization Software For Lesions

Radiology

System, Nuclear Magnetic Resonance Imaging

Radiology

Colon Computed Tomography System, Computer Aided Detection

Radiology

Instrument, Quality-Assurance, Radiologic

Radiology

Analyzer, Medical Image

Radiology

Dosimeter, Ionizing Radiation, Implanted

Radiology

Solid State Fluoroscopic X-Ray Imager

Radiology

Processor, Radiographic-Film, Automatic

Radiology

Test-Pattern, Radiographic

Radiology

Densitometer, Bone

Radiology

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Radiology

Radiological Software Device To Predict Future Breast Cancer Risk

Radiology

Device, Beam Limiting, X-Ray, Diagnostic

Radiology

Prostate Immobilizer Rectal Balloon

Radiology

Device, Communications, Images, Ophthalmic

Radiology

System, X-Ray, Mammographic

Radiology

Chair, Pneumoencephalographic

Radiology

Phantom, Anthropomorphic, Radiographic

Radiology

Changer, Radiographic Film/Cassette

Radiology

System, Applicator, Radionuclide, Remote-Controlled

Radiology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Radiology

Needle, Isotope, Gold, Titanium, Platinum

Radiology

Shield, Gonadal

Radiology

Source, Teletherapy, Radionuclide

Radiology

System, Image Processing, Radiological

Radiology

Arthrogram Tray

Radiology

Tube Mount, X-Ray, Diagnostic

Radiology

Device, Digital Image Storage, Radiological

Radiology

Post Breast Biopsy Hemostatic Breast Compression Device

Radiology

Collimator, Low Voltage, Therapeutic X-Ray

Radiology

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Radiology

Source, Isotope, Sealed, Gold, Titanium, Platinum

Radiology

Table, Radiologic

Radiology

System, Applicator, Radionuclide, Manual

Radiology

Programmer, Changer, Film/Cassette, Radiographic

Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Radiology

Holder, Radiographic Cassette, Wall-Mounted

Radiology

Radiographic Contrast Tray

Radiology

System, X-Ray, Fluoroscopic, Image-Intensified

Radiology

Automated Radiological Image Processing Software

Radiology

System, Imaging, X-Ray, Electrostatic

Radiology

Coil, Magnetic Resonance, Specialty

Radiology

Device, Spot-Film

Radiology