Other products from "BRONCUS MEDICAL INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00856571007258 10009-2 10009-2 Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. LLZ System, Image Processing, Radiological 2 Archimedes Access Key, 10-pack
2 00856571007241 10010 10010 The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver c The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site. GEI Electrosurgical, Cutting & Coagulation & Accessories 2 Empower RF Catheter
3 00856571007074 10008 10008 A sterile single use flexible tube with a balloon at or near the distal tip that A sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree. EOQ Bronchoscope (Flexible Or Rigid) 2 Archimedes Dilation Balloon
4 00856571007012 10005-1 10005-1 Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. EOQ Bronchoscope (Flexible Or Rigid) 2 FleXNeedle
5 00856571007296 10009-9 10009-9 A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. w/o Syringe EOQ Bronchoscope (Flexible Or Rigid) 2 Archimedes Access Kit
6 00856571007128 30009 30009 LungPoint Planning Software is software installed on a laptop computer used for LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. LLZ System, Image Processing, Radiological 2 LungPoint Planning System, v3.2
7 00856571007067 10007 10007 A sterile single use flexible tube that provides a working channel during a bron A sterile single use flexible tube that provides a working channel during a bronchoscopic procedure through which other devices may be introduced to the targeted area within the respiratory organs. The sheath is advanced through the working channel of a bronchoscope and allows for the repeated placement of endoscopic devices to a specified lesion(s) during a procedure. EOQ Bronchoscope (Flexible Or Rigid) 2 Archimedes Sheath
8 00856571007029 10009 10009 A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. EOQ Bronchoscope (Flexible Or Rigid) 2 Archimedes Access Kit
9 00856571007036 40005 40005 Archimedes software is installed on a desktop computer used to plan procedures a Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedure Module offers real-time navigation guidance for use during the bronchoscopy procedure. The Software provides the option to segment previously acquired CT or other DICOM data sets and overlay and register these segmented data sets onto live fluoroscopic X-ray images. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. LLZ System, Image Processing, Radiological 2 Archimedes System
10 00856571007210 10005-2 10005-2 Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. EOQ Bronchoscope (Flexible Or Rigid) 2 FleXNeedle (5 pack)
11 00856571007173 30005 30005 LungPoint VBN Software is software installed on a desktop computer used to plan LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. LLZ System, Image Processing, Radiological 2 LungPoint VBN System, V3.2
12 00856571007104 40009 40009 Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue. LLZ System, Image Processing, Radiological 2 Archimedes Planning System
13 00856571007234 12196-09 10009-09 A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. EOQ Bronchoscope (Flexible Or Rigid) 2 Archimedies Access Kit with Syringe
Other products with the same Product Code "LLZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 09421904268319 4.0 Volpara Density Map 4.0 Volpara Density Map VOLPARA HEALTH TECHNOLOGIES LIMITED
2 09421904268289 3.4.2 Volpara Density Map 3.4.2 Volpara Density Map VOLPARA HEALTH TECHNOLOGIES LIMITED
3 09421904268258 3.4.2 VolparaDensity 3.4.2 VolparaDensity VOLPARA HEALTH TECHNOLOGIES LIMITED
4 09421904268241 4.0 VolparaDensity VOLPARA HEALTH TECHNOLOGIES LIMITED
5 09421904268166 3.4.1 VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1) VolparaDensity VOLPARA HEALTH TECHNOLOGIES LIMITED
6 09421904268128 3.3 Volpara Density Map 3.3 Volpara Density Map VOLPARA HEALTH TECHNOLOGIES LIMITED
7 09421904268098 3.3 VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4) VolparaDensity VOLPARA HEALTH TECHNOLOGIES LIMITED
8 09421904268050 3.2 Volpara Density Map 3.2 Volpara Density Map VOLPARA HEALTH TECHNOLOGIES LIMITED
9 09421904268029 3.2 VolparaDensity 3.2 (Volpara Imaging Software 1.5.2) VolparaDensity VOLPARA HEALTH TECHNOLOGIES LIMITED
10 09358140000024 1.2 SCI0001 Quicktome OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
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12 09351327000848 1.2 1200-0000 OPSInsight™ is intended for use as preoperative surgical planning software to ai OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty. OPSInsight™ OPTIMIZED ORTHO PTY LTD
13 09351327000091 1250-1300 OPS Plan V.2.0 Optimized Positioning System (OPS) Plan OPTIMIZED ORTHO PTY LTD
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15 09120105730464 V2.11 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. KOALA IB LAB GMBH
16 09120105730037 V2.05 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. KOALA IB LAB GMBH
17 08908008302008 RADSpa RIS-PACS 4.0 RADSpa RIS-PACS RADSpa® TELERAD TECH PRIVATE LIMITED
18 08809466041112 1.2.1.466 QuantorView is an image viewing software dedicated DICOM images produced by imag QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration. QuantorView DIGIRAY CORP.
19 08809413810471 ExamVue PACS The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. Box for ExamVue PACS(outside 265mmx185mmx150mm) JPI HEALTHCARE. CO., LTD.
20 08809413810174 ExamVue PACS The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. ExamVue JPI HEALTHCARE. CO., LTD.
21 08809278790307 Xelis Dental 2.0 Xelis Dental 2.0 INFINITT HEALTHCARE CO.,LTD.
22 08809278790192 INFINITT RT PACS INFINITT RT PACS INFINITT HEALTHCARE CO.,LTD.
23 08809278790130 INFINITT PACS 7.0 INFINITT PACS INFINITT HEALTHCARE CO.,LTD.
24 08809278790123 INFINITT ULite INFINITT ULite INFINITT HEALTHCARE CO.,LTD.
25 08809278790116 Xelis Dental Xelis Dental INFINITT HEALTHCARE CO.,LTD.
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33 08806167789466 USO-U0N5B0K/WR 5D Viewer SAMSUNG MEDISON CO., LTD.
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35 08800086200064 V-B-pAb-02 Veuron-Brain-pAb2 HEURON CO.,LTD.
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45 08800022900089 1.0 1.0 VARO Plan Software is a stand-alone Windows-based software application to suppor VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry. VARO Plan 3D INDUSTRIAL IMAGING CO.,LTD
46 08800022900072 1.0 DentiqAir is a software application for the visualization and segmentation of im DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance. DentiqAir 3D INDUSTRIAL IMAGING CO.,LTD
47 08800022900041 1.0 DentiqGuide is a software device used to pre-operatively plan the placement of a DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock. DentiqGuide 3D INDUSTRIAL IMAGING CO.,LTD
48 08800022900003 1.0 1.0 Dentiq3D is a 3D visualization software for the analysis of various dental CT da Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions. Dentiq3D 3D INDUSTRIAL IMAGING CO.,LTD
49 08800019700357 3.3 EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. EzDent-i EWOO SOFT CO., LTD
50 08800019700340 5.4 Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. Ez3D-i EWOO SOFT CO., LTD