| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | M776CHRCO100 | G3 | CHR-CO-100 | The Pulmonx® Chartis System is designed to measure pressure and flow in order to The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device. | BZG | Spirometer, Diagnostic | 2 | Chartis Console |
| 2 | 00811907031222 | EDC-TS-5.5-DM | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) selfexpanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 3 | 00811907030720 | EDC-TS-5.5 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 4 | 00811907030621 | EDC-TS-4.0-J | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 5 | 00811907030522 | EDC-TS-4.0 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 6 | 00811907030423 | EBV-TS-5.5-LP | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 7 | 00811907030324 | EBV-TS-5.5 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 8 | 00811907030225 | EBV-TS-4.0-LP | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 9 | 00811907030126 | EBV-TS-4.0 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 10 | 00811907031161 | CHR-CO-300 | The Chartis Tablet Console is a two-part spirometry system comprised of a touchs The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. Theballoon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time. | BZG | Spirometer, Diagnostic | 2 | Pulmonx Chartis Tablet Console | |
| 11 | 00811907031123 | CHR-CO-300 | The Chartis Tablet Console is a two-part spirometry system comprised of a touchs The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time. | BZG | Spirometer, Diagnostic | 2 | Pulmonx Chartis Tablet Console | |
| 12 | M776CHRCA120 | G3 | CHR-CA-12.0 | The Chartis Catheter is a single use, sterile, disposable device designed to be The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter. | CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 | Chartis Catheter |
| 13 | 00811907030928 | G3 | CHR-CA-12.0 | The Chartis Catheter is a single use, sterile, disposable device designed to be The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter. | CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 | Chartis Catheter |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 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 | |
| 3 | 08908002051063 | V2 | MAXIO V2 is a stereotactic accessory intended for the spatial positioning and or MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided procedures. It provides Preoperative planning and intra operative guidance to the surgeon by visually representing the targeted path and position(s) on the image based model of the target organ along with the data provided by the instrument manufacturer. | MAXIO | PERFINT HEALTHCARE PRIVATE LIMITED | |
| 4 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 5 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 6 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 7 | 08033837932994 | NewTom 7G | 70V10000 | The device NewTom 7G is a cone beam computed tomography X-ray system. It is inte The device NewTom 7G is a cone beam computed tomography X-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area. | NewTom | CEFLA SOCIETA' COOPERATIVA |
| 8 | 08033837931379 | NewTom 5G XL | P70720008 | X-ray imaging device comprising an X-ray acquisition system, for producing two a X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display. | NewTom | CEFLA SOCIETA' COOPERATIVA |
| 9 | 08033837931362 | NewTom 5G | P70720000 | X-ray imaging device comprising an X-ray acquisition system, for producing two a X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display. | NewTom | CEFLA SOCIETA' COOPERATIVA |
| 10 | 07640167222131 | 2.0 | CAS-One IR | CASCINATION AG | ||
| 11 | 07290108670127 | VERITON CT 16 | 8010172-01 | Single Photon Emission Computed Tomography System combined with a Computed Tomog Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging. | VERITON CT | SPECTRUM DYNAMICS MEDICAL, INC |
| 12 | 07290108670110 | VERITON CT 64 | 8010142-01 | Single Photon Emission Computed Tomography System combined with a Computed Tomog Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging, | VERITON CT | SPECTRUM DYNAMICS MEDICAL, INC |
| 13 | 07290018016114 | 1.1 | HealthOST | NANO-X AI LTD | ||
| 14 | 07290018016091 | 1.0 | HealthCCSng | NANO-X AI LTD | ||
| 15 | 07290018016008 | 3.0.0 | HealthCCS | NANO-X AI LTD | ||
| 16 | 07290017702254 | D | XR-ACE-SYS | XACT ACE Robotic System | ACE | XACT ROBOTICS LTD |
| 17 | 07290016836202 | 1.0 | Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check function Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, inaccordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. Thedevice is a software and hardware system which includes Computer, dedicated display andcontrols. The SafeCT-29 is interfaced to CT scanners that are not equipped with the DoseCheck function. The device is connected to the CT Console video output via a standard videoconnector. The SafeCT-29 Computer’s internal video splitter captures the CT Console displayvideo, in real time, without affecting neither the CT console itself nor its display. This analogvideo signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital inputvideo using OCR software continuously. The radiation dose information as calculated by thescanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT-29 captures the video of the CT Console display in real time, without affecting neither the CTconsole itself nor its display and workflow. As specified by NEMA XR-25 Standard, thesafeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index isabove the predefined values set by the operating group, practice, or organization. SafeCT-29prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator,in accordance with NEMA XR-29*.The device records the details of such events, includingthe operator details and decisions. This record is available to the user. | SafeCT-29 | MEDIC VISION - IMAGING SOLUTIONS LTD | |
| 18 | 07290016484007 | Spotlight | The CardioGraphe is a CT Scanner designed to provide images of scanned organs es The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system. | CardioGraphe | ARINETA LTD | |
| 19 | 06971576832057 | uMI 550 | uMI | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | ||
| 20 | 06971576832040 | uEXPLORER | Positron Emission Tomography and Computed Tomography System | uEXPLORER | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 21 | 06971576832026 | uMI 550 | Positron Emission Tomography and Computed Tomography System | uMI | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 22 | 06971576831104 | uCT ATLAS | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | ||
| 23 | 06971576831043 | uCT 760 | Computed Tomography X-ray System | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 24 | 06971576831036 | uCT 550 | Computed Tomography X-ray System | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 25 | 06971576831012 | uCT 530 | Computed Tomography X-ray System | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 26 | 06970167440084 | NeuViz 16 Essence | NeuViz 16 Essence Multi-Slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 27 | 06970167440077 | NeuViz Prime | NeuViz Prime Multi-Slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 28 | 06970167440060 | NeuSight PET/CT 16 | NeuSight PET/CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 29 | 06970167440053 | NeuSight PET/CT 64 | NeuSight PET/CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 30 | 06970167440046 | NeuViz 128 | NeuViz 128 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 31 | 06970167440039 | NeuViz 64 En | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 32 | 06970167440022 | NeuViz 64 In | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 33 | 06970167440015 | NeuViz 64e | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 34 | 06970167440008 | NeuViz 64i | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 35 | 06009880828166 | eXero-dr | CL-08-0013-H2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 36 | 06009880828159 | Xmplar-dr | CL-08-0015-B2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 37 | 06009880828142 | eXero-dr | CL-08-0013-H4 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 38 | 06009880828135 | Xmplar-dr | CL-08-0013-A11 | The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images used for diagnosis purpose in both trauma and general radiography cases, as well as forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 39 | 06009880828128 | eXero-dr | CL-08-0013-H11 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposesin both trauma and general radiography cases as well as in forensic pathology cases. | Lodox | LODOX SYSTEMS (PTY) LTD |
| 40 | 06009880828111 | Xmplar-dr | CL-08-0015-B1 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 41 | 06009880828104 | Xmplar-dr | CL-08-0012-A8 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 42 | 06009880828098 | Xmplar-dr | CL-08-0012 | The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ra The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 43 | 06009880828081 | eXero-dr | CL-08-0016-I2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 44 | 06009880828074 | eXero-dr | CL-08-0013-H7 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases. | Lodox | LODOX SYSTEMS (PTY) LTD |
| 45 | 06009880828067 | eXero-dr | CL-08-0013-H6 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases. | Lodox | LODOX SYSTEMS (PTY) LTD |
| 46 | 05700002173614 | v.1. | RBknee | RADIOBOTICS APS | ||
| 47 | 04987670103810 | PCD-1000A | This device is used to acquire transaxial images of any desired region of the bo This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities. | PET-CT SCANNER | CANON MEDICAL SYSTEMS CORPORATION | |
| 48 | 04987670103797 | TSX-306A | CT SCANNER | CANON MEDICAL SYSTEMS CORPORATION | ||
| 49 | 04987670102912 | TSX-303B | This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SCANNER.Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now CT SCANNER . | TOSHIBA SCANNER | CANON MEDICAL SYSTEMS CORPORATION | |
| 50 | 04987670102691 | TSX-304A | CT SCANNER | CANON MEDICAL SYSTEMS CORPORATION |