Other products from "INVIVO CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00884838081536 45353038409 Sentinelle MR 1.5T Breast Imaging Table MOS Coil, magnetic resonance, specialty 2 Invivo
2 00884838073159 98960320913 Grid Plate, Enhanced Access, lat. GDF GUIDE, NEEDLE, SURGICAL 1 Invivo
3 00884838072831 98960320335 Coax Needle KNW INSTRUMENT, BIOPSY 2 Invivo
4 00884838065673 45353025228 dS Wrist 8CH 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
5 00884838081550 784015 UroNav Fusion Biopsy Software JAK System, x-ray, tomography, computed 2 Invivo
6 00884838067417 45353036082 SENSE XL Torso Coil MOS Coil, magnetic resonance, specialty 2 Invivo
7 00884838066854 45353028072 dS Breast 16CH 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
8 00884838067240 45353031542 HD 8CH Wrist Array MOS Coil, magnetic resonance, specialty 2 Invivo
9 00884838067202 45353030472 1.5T HD T/R Knee Coil (flat base) MOS Coil, magnetic resonance, specialty 2 Invivo
10 00884838067189 45353031519 HD 8CH Wrist Array MOS Coil, magnetic resonance, specialty 2 Invivo
11 00884838067134 107629 HD 8Ch NV Array MOS Coil, magnetic resonance, specialty 2 Invivo
12 00884838067110 106614 HD T/R Quad Extremity Coil LNH System, nuclear magnetic resonance imaging 2 Invivo
13 00884838067103 109183 HD 8CH Foot Ankle Coil (Receive Only) MOS Coil, magnetic resonance, specialty 2 Invivo
14 00884838067097 585TO-64 Phased Array ABFLEX Coil MOS Coil, magnetic resonance, specialty 2 Invivo
15 00884838067042 106453 HD 4Ch Breast Array (Receive Only) MOS Coil, magnetic resonance, specialty 2 Invivo
16 00884838066908 45353032243 dS Flex-S MOS Coil, magnetic resonance, specialty 2 Invivo
17 00884838105348 4598-018-57611 dS 1.5T Medial Plug MOS Coil, Magnetic Resonance, Specialty 2 Sentinelle
18 00884838072978 98960320349 Needle Sleeve KNW INSTRUMENT, BIOPSY 2 Invivo
19 00884838098497 459801730021 dS Knee 16 Ch 1.5T MOS Coil, Magnetic Resonance, Specialty 2 Invivo
20 00884838065390 45353031035 SENSE MSK M 8CH 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
21 00884838086166 45980129063 dS Knee 8Ch 3.0T MOS Coil, magnetic resonance, specialty 2 Invivo
22 00884838066953 45353033812 SENSE Torso 8 MOS Coil, magnetic resonance, specialty 2 Invivo
23 00884838066205 103345 Breast Biopsy Array Coil MOS Coil, magnetic resonance, specialty 2 Invivo
24 00884838081529 101759 1.5T KFA with coil ID MOS Coil, magnetic resonance, specialty 2 Invivo
25 00884838081512 472GE-42 1.0T Quadrature Lower Extremity Coil LNH System, nuclear magnetic resonance imaging 2 Invivo
26 00884838073227 98960320446 Bone Biopsy Set, manual KNW INSTRUMENT, BIOPSY 2 Invivo
27 00884838073210 98960320370 Handle KNW INSTRUMENT, BIOPSY 2 Invivo
28 00884838073203 98960320369 Working Tube Set KNW INSTRUMENT, BIOPSY 2 Invivo
29 00884838073197 98960320368 Bone Biopsy Drill Set, manual KNW INSTRUMENT, BIOPSY 2 Invivo
30 00884838073180 98960320365 Bone Biopsy Set, manual KNW INSTRUMENT, BIOPSY 2 Invivo
31 00884838073173 98960320914 Lateral Grid dS Breast 16CH I/T MOS Coil, magnetic resonance, specialty 2 Invivo
32 00884838073166 98960320915 Medial Grid dS Breast 16CH I/T MOS Coil, magnetic resonance, specialty 2 Invivo
33 00884838073142 98960320912 Grid Plate, Enhanced Access, med. GDF GUIDE, NEEDLE, SURGICAL 1 Invivo
34 00884838073135 98960320910 Pillar Immobilization Plate MOS Coil, magnetic resonance, specialty 2 Invivo
35 00884838072848 98960320336 Coax Needle KNW INSTRUMENT, BIOPSY 2 Invivo
36 00884838072824 98960320334 Coax Needle KNW INSTRUMENT, BIOPSY 2 Invivo
37 00884838065666 100313 Breast Array Coil (Receive Only) MOS Coil, magnetic resonance, specialty 2 Invivo
38 00884838065659 45353005761 SENSE Head Coil 1.5T/8CH MOS Coil, magnetic resonance, specialty 2 Invivo
39 00884838085510 784016 DynaLync Prostate OUG Medical device data system 1 Invivo
40 00884838081673 45353033613 dS HiRes Hand/Wrist 16Ch 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
41 00884838081666 45980077811 dS Small Extremity 16ch 3.0T MOS Coil, magnetic resonance, specialty 2 Invivo
42 00884838081659 45980087863 dS Small Extremity 16Ch 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
43 00884838081635 45353033611 dS Shoulder 16Ch 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
44 00884838081628 10606922 2 Channel Endo Coil Array for Siemens 3T MOS Coil, magnetic resonance, specialty 2 Invivo
45 00884838081611 10606920 Prostate 2 MR Coil 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
46 00884838081581 45353038361 Breast MRI 8ch Tabletop for Siemens 3T MOS Coil, magnetic resonance, specialty 2 Invivo
47 00884838081604 45353038386 Breast MRI 16ch Tabletop for Siemens 3T IYN System, imaging, pulsed doppler, ultrasonic 2 Invivo
48 00884838081598 45353038382 Breast MRI 16ch Tabletop for Siemens 1.5T IYN System, imaging, pulsed doppler, ultrasonic 2 Invivo
49 00884838081574 45353038349 Breast MRI 8ch Tabletop for Siemens 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
50 00884838081567 45353038366 Breast MRI 4ch Tabletop for Siemens 1.5T MOS Coil, magnetic resonance, specialty 2 Invivo
Other products with the same Product Code "LLZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00628914000017 eUnity-1 eUnity software is a diagnostic medical imaging display workstation. As part of eUnity software is a diagnostic medical imaging display workstation. As part of an EMR, Portal or as a stand-alone application, eUnity provides secure access to full-fidelity DICOM images with unprecedented performance using nothing more than a common web-browser (no client software to manage.) Medical professionals can now access medical images across multiple sites and multiple PACS using eUnity as their image viewing platform. eUnity CLIENT OUTLOOK INC
2 00628678950016 2.x.y Version 2.7.0 densitas® densityAI™ DENSITAS INCORPORATED
3 00628451892021 1 P008943 The Halifax Imaging Kit is part of the SR Suite product line, provides an altern The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path tocreating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Raycomponents integrated into an existing digital radiography room already containing an FDAcleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kitand the existing DR system are synchronized by replacing the trigger switches of the twosystems with the Halifax Synchronization Switch. The Halifax Synchronization Switchensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray imagesfrom two different perspectives to be taken at the exact same time. This process allows forRoentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR).RSA is a stereo x-ray technique that enables measurements more accurate and precise thansingle plane radiography based on phantom studies. The increased level of precision enablesmeasurement of implant stability. Halifax Imaging Kit HALIFAX BIOMEDICAL INCORPORATED
4 00628105001762 7.6 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers a simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
5 00628105001755 7.5 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
6 00628105001748 7.4 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
7 00628105001731 7.3 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologist, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
8 00628055858010 2.0 Fusion Bx 2.0 is designed to display the 2D live video received from commerciall Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. Fusion Bx FOCAL HEALTHCARE INC
9 00628055858003 1.1 Fusion Bx is designed to display the 2D live video received from commercially av Fusion Bx is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer.Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. Encoders in the stepper and tracker send joint movement information to the computer workstation which tracks probe position and orientation. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Fusion Bx. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate and to display the live image position within the prostate. Fusion Bx FOCAL HEALTHCARE INC
10 00628011382160 1.6.0 Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). Limbus Contour LIMBUS AI INC.
11 00628011382153 1.5.0 Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). Limbus Contour LIMBUS AI INC.
12 00628011382146 1.4.0 Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). Limbus Contour LIMBUS AI INC.
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