No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00815686020064 | SYS-2000 | SYS-2000 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System V2, 120V, 60Hz | |
2 | 00815686020057 | SYS-1500 | SYS-1500 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNView System | |
3 | 00815686021108 | INS-5700 | INS-5700 | JAK | System, X-Ray, Tomography, Computed | SPiN EWC – Biopsy Guide Kit | ||
4 | 00815686021078 | SFT-0007 | SFT-0007 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNDrive Software Application | |
5 | 00815686020736 | INS-5600 | INS-5600 | JAK | System, X-Ray, Tomography, Computed | SPiNPerc Biopsy Needle Guide Kit | ||
6 | 00815686020071 | SYS-2230 | SYS-2230 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System V2, 230V, 50Hz | |
7 | 00815686020590 | INS-0382 | INS-0382 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked 19ga ANSO Histology Needle, 15mm L, 1.8mm OD | ||
8 | 00815686020538 | INS-0352 | INS-0352 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Brush, 15mm L, 1.8mm OD | |
9 | 00815686020033 | SYS-0185 | SYS-0185 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNPlanning Laptop Workstation | |
10 | 00815686020446 | INS-0305 | INS-0305 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Guidewire, 1.0mm, 950mm | |
11 | 00815686021290 | INS-5915 | INS-5915 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Olympus 190 Scopes | |
12 | 00815686021269 | INS-5905 | INS-5905 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Olympus Scopes | |
13 | 00815686020354 | INS-5034 | INS-5034 | JAK | System, X-Ray, Tomography, Computed | 17ga LG, 123mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
14 | 00815686020293 | INS-5028 | INS-5028 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
15 | 00815686020279 | INS-5026 | INS-5026 | JAK | System, X-Ray, Tomography, Computed | 18ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
16 | 00815686020576 | INS-0372 | INS-0372 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked Forceps, 1.8mm OD, Serrated Cup | ||
17 | 00815686020477 | INS-0322 | INS-0322 | JAK | System, X-Ray, Tomography, Computed | 2 | View Peripheral Catheter, 3.2mm OD, 2.0mm WC | |
18 | 00815686021153 | INS-5900 | INS-5900 | JAK | System, X-Ray, Tomography, Computed | SPiN Access Catheter - Biopsy Guide Kit | ||
19 | 00815686021313 | INS-5925 | INS-5925 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Pentax Scopes | |
20 | 00815686021276 | INS-5910 | INS-5910 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes | |
21 | 00815686021177 | INS-5911 | INS-5911 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 90 Degree Catheter | |
22 | 00815686021146 | INS-5611 | INS-5611 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Localization Needle 19ga x 105mm, 2cm marking zone | ||
23 | 00815686020361 | INS-5036 | INS-5036 | JAK | System, X-Ray, Tomography, Computed | 22 UTW, 125mm Always-On Tip Tracked Biopsy Needle, Trocar Point | ||
24 | 00815686020323 | INS-5031 | INS-5031 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
25 | 00815686020262 | INS-5025 | INS-5025 | JAK | System, X-Ray, Tomography, Computed | 18ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
26 | 00815686020118 | SYS-4230 | SYS-4230 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Thoracic Navigation System, 230V, 50Hz | |
27 | 00815686020088 | SYS-3000 | SYS-3000 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System, 120V, 60Hz | |
28 | 00815686020712 | INS-5323 | INS-5323 | JAK | System, X-Ray, Tomography, Computed | Slidding Stopper 1.4 - 1.9 OD | ||
29 | 00815686021122 | INS-5620 | INS-5620 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Kit | ||
30 | 00815686021061 | SFT-0004 | SFT-0004 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4IR Software Application | |
31 | 00815686020439 | INS-0304 | INS-0304 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Trip Tracked Guidewire, 1.0mm, 735mm | |
32 | 00815686020392 | INS-0048 | INS-0048 | JAK | System, X-Ray, Tomography, Computed | 2 | vPad2 Connector Cable | |
33 | 00815686021252 | INS-5903 | INS-5903 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Pentax | |
34 | 00815686021160 | INS-5901 | INS-5901 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Locking Device, Olympus | |
35 | 00815686020309 | INS-5029 | INS-5029 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
36 | 00815686020255 | INS-5024 | INS-5024 | JAK | System, X-Ray, Tomography, Computed | 17ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
37 | 00815686020231 | INS-5022 | INS-5022 | JAK | System, X-Ray, Tomography, Computed | 17ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
38 | 00815686020651 | INS-5450 | INS-5450 | JAK | System, X-Ray, Tomography, Computed | SPiN Xtend 2.0mm OD, 21ga | ||
39 | 00815686020514 | INS-0342 | INS-0342 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked 20ga Aspiration Needle, 15mm L, 1.8mm OD | |
40 | 00815686021085 | SFT-0010 | SFT-0010 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNPlanning Software Application | |
41 | 00815686020927 | INS-5035 | INS-5035 | JAK | System, X-Ray, Tomography, Computed | 17ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
42 | 00815686021245 | INS-5902 | INS-5902 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Olympus 190 | |
43 | 00815686021207 | INS-5300 | INS-5300 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD | |
44 | 00815686020217 | INS-5016 | INS-5016 | JAK | System, X-Ray, Tomography, Computed | 17ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
45 | 00815686020705 | INS-5040 | INS-5040 | JAK | System, X-Ray, Tomography, Computed | Always-On TIp Tracked Universal Tracker, LG, 7-12ga | ||
46 | 00815686020644 | INS-5440 | INS-5440 | JAK | System, X-Ray, Tomography, Computed | View Peripheral Catheter, 3.8mm OD, 2.5mm WC | ||
47 | 00815686021139 | INS-5610 | INS-5610 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Localization Needle 19ga x 105mm, 1cm marking zone | ||
48 | 00815686020286 | INS-5027 | INS-5027 | JAK | System, X-Ray, Tomography, Computed | 18ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
49 | 00815686020248 | INS-5023 | INS-5023 | JAK | System, X-Ray, Tomography, Computed | 17ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
50 | 00815686020224 | INS-5017 | INS-5017 | JAK | System, X-Ray, Tomography, Computed | 17ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point |
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 |