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    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, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

    FDA Enforcement
    Class II ·Ongoing·Hologic Inc·October 2, 2024

    GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 7, 2014

    GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 25, 2013

    GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 31, 2012

    GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 26, 2014

    Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed: " CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE OF FOLLOWING APPLICATIONS IS INSTALLED: ¿ VesselIQ Xpress or AVA Xpress ¿ CardIQ Xpress Pro or Plus ¿ CardEP ¿ CardIQ Fusion PET or SPECT provided with Volume Viewer 3 and 3.1 from versions 7.0 to 7.5 and 8.1. To verify the version installed on your system: Select the Admin menu from the Patient list page. Then select Display Configuration. You will find the version of your system in Installed Application(s). This version will appear as vxtl_7.x or vxtl_8.x. Intended use: K993792: Smart Vessel Analysis (Smart VA) is a software post-processing option for the Advantage Workstation (AW) platform, which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization. K031261: Card EP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy. K041267: CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis II will run on the AW workstation, scanner operator console and PACS system. K061370: CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data. CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information. With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in severa

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 26, 2012

    GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 28, 2013

    VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 17, 2013

    GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 2, 2013

    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 20, 2013

    GE Healthcare, Proteus XR/a with wall stand model number 600-0301.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·January 21, 2015

    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 Product Usage: Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 22, 2012

    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 7, 2017

    SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 21, 2013

    GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes, but is not limited to: electrocardiogram, invasive blood pressure, noninvasive blood pressure (NBP), heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 26, 2012

    GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 30, 2014

    GE Healthcare, Avance, Avance CS2, Amingo.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 21, 2016

    Ami HTX.

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    FDA Enforcement
    Class II ·Terminated·Apollo Endosurgery Inc·October 8, 2014