No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00887517399779 | 6942044 | CoRoent® XLR, 20x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
2 | 00887517399700 | 6941844 | CoRoent® XLR, 18x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
3 | 00887517399335 | 6941644 | CoRoent® XLR, 16x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
4 | 00887517398765 | 6941444 | CoRoent® XLR, 14x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
5 | 00887517398499 | 6941244 | CoRoent® XLR, 12x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
6 | 00887517398420 | 6941044 | CoRoent® XLR, 10x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
7 | 00887517398055 | 6932088 | CoRoent® XLR, 20x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
8 | 00887517397683 | 6931888 | CoRoent® XLR, 18x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
9 | 00887517397256 | 6931688 | CoRoent® XLR, 16x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
10 | 00887517396822 | 6931488 | CoRoent® XLR, 14x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
11 | 00887517396457 | 6931288 | CoRoent® XLR, 12x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
12 | 00887517395641 | 6922088 | CoRoent® XLR, 20x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
13 | 00887517395634 | 6922044 | CoRoent® XLR, 20x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
14 | 00887517395269 | 6921888 | CoRoent® XLR, 18x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
15 | 00887517395252 | 6921844 | CoRoent® XLR, 18x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
16 | 00887517394880 | 6921688 | CoRoent® XLR, 16x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
17 | 00887517394873 | 6921660 | CoRoent® XL Wide, 16x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
18 | 00887517394866 | 6921655 | CoRoent® XL Wide, 16x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
19 | 00887517394859 | 6921650 | CoRoent® XL Wide, 16x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
20 | 00887517394842 | 6921645 | CoRoent® XL Wide, 16x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
21 | 00887517394835 | 6921644 | CoRoent® XLR, 16x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
22 | 00887517394569 | 6921488 | CoRoent® XLR, 14x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
23 | 00887517394552 | 6921460 | CoRoent® XL Wide, 14x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
24 | 00887517394545 | 6921455 | CoRoent® XL Wide, 14x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
25 | 00887517394538 | 6921450 | CoRoent® XL Wide, 14x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
26 | 00887517394521 | 6921445 | CoRoent® XL Wide, 14x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
27 | 00887517394514 | 6921444 | CoRoent® XLR, 14x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
28 | 00887517394149 | 6921288 | CoRoent® XLR, 12x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
29 | 00887517394132 | 6921260 | CoRoent® XL Wide, 12x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
30 | 00887517394125 | 6921255 | CoRoent® XL Wide, 12x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
31 | 00887517394118 | 6921250 | CoRoent® XL Wide, 12x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
32 | 00887517394101 | 6921245 | CoRoent® XL Wide, 12x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
33 | 00887517393791 | 6921244 | CoRoent® XLR, 12x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
34 | 00887517393722 | 6921088 | CoRoent® XLR, 10x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
35 | 00887517393715 | 6921060 | CoRoent® XL Wide, 10x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
36 | 00887517393708 | 6921055 | CoRoent® XL Wide, 10x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
37 | 00887517393395 | 6921050 | CoRoent® XL Wide, 10x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
38 | 00887517393388 | 6921045 | CoRoent® XL Wide, 10x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
39 | 00887517393371 | 6921044 | CoRoent® XLR, 10x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
40 | 00887517393333 | 6920860 | CoRoent® XL Wide, 8x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
41 | 00887517393326 | 6920855 | CoRoent® XL Wide, 8x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
42 | 00887517393319 | 6920850 | CoRoent® XL Wide, 8x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
43 | 00887517393302 | 6920845 | CoRoent® XL Wide, 8x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
44 | 00887517392961 | 6916860 | CoRoent® XL, 16x18x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
45 | 00887517392954 | 6916855 | CoRoent® XL, 16x18x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
46 | 00887517392947 | 6916850 | CoRoent® XL, 16x18x50mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
47 | 00887517392930 | 6916845 | CoRoent® XL, 16x18x45mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
48 | 00887517392923 | 6916840 | CoRoent® XL, 16x18x40mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
49 | 00887517392916 | 6916260 | CoRoent® XL Wide, 16x22x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
50 | 00887517392909 | 6916255 | CoRoent® XL Wide, 16x22x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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. | |
2 | 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. | |
3 | 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. | |
4 | 08809278790307 | Xelis Dental 2.0 | Xelis Dental 2.0 | INFINITT HEALTHCARE CO.,LTD. | ||
5 | 08809278790192 | INFINITT RT PACS | INFINITT RT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
6 | 08809278790130 | INFINITT PACS 7.0 | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
7 | 08809278790123 | INFINITT ULite | INFINITT ULite | INFINITT HEALTHCARE CO.,LTD. | ||
8 | 08809278790116 | Xelis Dental | Xelis Dental | INFINITT HEALTHCARE CO.,LTD. | ||
9 | 08809278790109 | Xelis Cardiac | Xelis Cardiac | INFINITT HEALTHCARE CO.,LTD. | ||
10 | 08809278790093 | Xelis Fusion | Xelis Fusion | INFINITT HEALTHCARE CO.,LTD. | ||
11 | 08809278790086 | Xelis 3D | Xelis 3D | INFINITT HEALTHCARE CO.,LTD. | ||
12 | 08809278790079 | Xelis | Xelis | INFINITT HEALTHCARE CO.,LTD. | ||
13 | 08809278790062 | INFINITT Cardiology PACS | INFINITT Cardiology PACS | INFINITT HEALTHCARE CO.,LTD. | ||
14 | 08809278790055 | INFINITT PACS | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
15 | 08809278790000 | STARPACS | STARPACS | INFINITT HEALTHCARE CO.,LTD. | ||
16 | 08809246620049 | SPINEL 12HD | SPINEL 12HD | SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide flu SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. | Interventional Fluoroscopic Mobile X-ray System | GEMSS MEDICAL SYSTEMS CO.,LTD. |
17 | 08809246620049 | SPINEL 12HD | SPINEL 12HD | SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide flu SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. | Interventional Fluoroscopic Mobile X-ray System | GEMSS MEDICAL SYSTEMS CO.,LTD. |
18 | 08809246620025 | KMC-650 | KMC-650 | The KMC-650 is a great solution to produce radiological images of patient during The KMC-650 is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital. | Image-intensified fluoroscopic x-ray system, mobile | GEMSS MEDICAL SYSTEMS CO.,LTD. |
19 | 08809246620018 | SPINEL 3G | SPINEL 3G | The SPINEL 3G is a great solution to produce radiological images of patient duri The SPINEL 3G is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital. | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE | GEMSS MEDICAL SYSTEMS CO.,LTD. |
20 | 08809246620001 | KMC-950 | KMC-950 | The KMC-950 is a great solution to produce radiological images of patient during The KMC-950 is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital. | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED | GEMSS MEDICAL SYSTEMS CO.,LTD. |
21 | 08809246620001 | KMC-950 | KMC-950 | The KMC-950 is a great solution to produce radiological images of patient during The KMC-950 is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital. | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED | GEMSS MEDICAL SYSTEMS CO.,LTD. |
22 | 08809244061219 | OSCAR 15 | Genoray | GENORAY CO., LTD. | ||
23 | 08809244061219 | OSCAR 15 | Genoray | GENORAY CO., LTD. | ||
24 | 08809244060120 | ZEN-2090 Turbo | Genoray | GENORAY CO., LTD. | ||
25 | 08809244060120 | ZEN-2090 Turbo | Genoray | GENORAY CO., LTD. | ||
26 | 08809244060113 | OSCAR Classic | Genoray | GENORAY CO., LTD. | ||
27 | 08809244060113 | OSCAR Classic | Genoray | GENORAY CO., LTD. | ||
28 | 08809244060106 | OSCAR Prime | Genoray | GENORAY CO., LTD. | ||
29 | 08809244060106 | OSCAR Prime | Genoray | GENORAY CO., LTD. | ||
30 | 08809244060083 | ZEN-7000 | Genoray | GENORAY CO., LTD. | ||
31 | 08809244060083 | ZEN-7000 | Genoray | GENORAY CO., LTD. | ||
32 | 08809244060021 | ZEN-2090 Pro | Genoray | GENORAY CO., LTD. | ||
33 | 08806167789466 | USO-U0N5B0K/WR | 5D Viewer | SAMSUNG MEDISON CO., LTD. | ||
34 | 08806167761172 | USO-U0N5B0B/WR | 5D VIEWER | SAMSUNG MEDISON CO., LTD. | ||
35 | 08800086200064 | V-B-pAb-02 | Veuron-Brain-pAb2 | HEURON CO.,LTD. | ||
36 | 08800086200026 | V-B-pAb-01 | Veuron-Brain-pAb | HEURON CO.,LTD. | ||
37 | 08800086200019 | V-B-mN1-01 | Veuron-Brain-mN1 | HEURON CO.,LTD. | ||
38 | 08800046800006 | 1.1.0 | ClariCT.AI | CLARIPI INC. | ||
39 | 08800043830006 | CUVIS-spine | CA-00000-000 | N/A | CUREXO, INC. | |
40 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
41 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
42 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
43 | 08800025300022 | 1.1 | AVIEW Modeler | CORELINE SOFT CO.,LTD. | ||
44 | 08800025300015 | 1.0 | AVIEW | CORELINE SOFT CO.,LTD. | ||
45 | 08800023100006 | 1.0 | OnDemand3DTM | CYBERMED INC. | ||
46 | 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 |
47 | 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 | |
48 | 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 | |
49 | 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 |
50 | 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 |