No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05415334027343 | MNA-440 DEC | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
2 | 05415334026612 | MDSC-8255 | K930793302B | MDSC-8255 LED NG | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | Barco |
3 | 05415334000926 | MNA-120 | K9303151A | MNA-120 ENC ANA AUDIO TMS+CBL | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis |
4 | 05415334000667 | MNA-110 | K9303032A | MNA-110 ENC HDSDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis |
5 | 05415334033047 | Nexxis | K9605026 | NEXXIS SYSTEM X620 CM V3 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
6 | 05415334002029 | MDNC-2123 | K9300331A | MDNC-2123 DE WP | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
7 | 05415334002005 | MDNC-2221 | K9301654B | MDNC-2221 EM | LLZ | System, image processing, radiological | 2 | Nio Color 2MP |
8 | 05415334000384 | MDNC-2123 | K9300330A | MDNC-2123 DE WH | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
9 | 05415334000377 | MDNC-2123 | K9300332A | MDNC-2123 EM BL | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
10 | 05415334025974 | MDCC-6530 | K9301638A | MDCC-6530 NC | PGY | Display, diagnostic radiology | 2 | Coronis Fusion 6 MP |
11 | 05415334028401 | MDNG-6221 | K9300371B | MDNG-6221 NC EM | PGY | Display, Diagnostic Radiology | 2 | Nio 5.8MP Gray |
12 | 05415334002357 | MDNC-2123 | K9300330B | MDNC-2123 DE WH MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
13 | 05415334002326 | MDCC-6530 | K9301636A | MDCC-6530 | PGY | Display, diagnostic radiology | 2 | Coronis Fusion 6 MP |
14 | 05415334036895 | MDNG-6221 | K9300370B | MDNG-6221 SPEF | PGY | Display, Diagnostic Radiology | 2 | Nio 5.8MP Gray |
15 | 05415334036888 | MDNG-6221 | K9300372B | MDNG-6221 SNEF | PGY | Display, Diagnostic Radiology | 2 | Nio 5.8MP Gray |
16 | 05415334001541 | MDNG-5121 | K9300266C | MDNG-5121 CB (MA) | LLZ | System, image processing, radiological | 2 | MDNG-5121 CB (MA) |
17 | 05415334002623 | MDNC-2123 | K9300333B | MDNC-2123 NEU MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
18 | 05415334002616 | MDNC-2123 | K9300332B | MDNC-2123 EM BL MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
19 | 05415334002609 | MDNC-2123 | K9300331B | MDNC-2123 DE WP MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
20 | 05415334001992 | MDNC-3421 | K9300347A | MDNC-3421 EM | PGY | Display, diagnostic radiology | 2 | Nio Color 3MP |
21 | 05415334001916 | MDNC-3421 | K9300346A | MDNC-3421 DE | PGY | Display, diagnostic radiology | 2 | Nio Color 3MP |
22 | 05415334031326 | MDNC-3421II | K9300347B | MDNC-3421 EM MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 3MP |
23 | 05415334030411 | MDNG-5221 | K9300350C | MDNG-5221 CB MKIII | LLZ | System, Image Processing, Radiological | 2 | Nio 5MP LED |
24 | 05415334030312 | MDNG-5221 | K9300351C | MDNG-5221 BB MKIII | LLZ | System, Image Processing, Radiological | 2 | Nio 5MP LED |
25 | 05415334002678 | MNA-440 | K9303310G | MNA-440 DEC HDMI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
26 | 05415334002661 | MNA-440 | K9303310F | MNA-440 DEC HDMI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
27 | 05415334002654 | MNA-440 | K9303310B | MNA-440 DEC HDMI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
28 | 05415334002647 | MNA-440 ENC | K9303301 | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
29 | 05415334002630 | MNA-420 ENC | K9303321 | MNA-420 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
30 | 05415334027398 | MNA-420 DEC | k9303331B | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
31 | 05415334027381 | MNA-420 DEC | k9303331X | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
32 | 05415334027374 | MNA-440 DEC | k9303311x | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
33 | 05415334027367 | MNA-440 DEC | k9303311B | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
34 | 05415334027350 | MNA-440 DEC | k9303311F | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
35 | 05415334027336 | MNA-420 DEC | k9303331F | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
36 | 05415334027329 | MNA-420 DEC | K9303331G | MNA-420 DEC HDMI V2 UK | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
37 | 05415334027312 | MNA-420 DEC | k9303331I | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
38 | 05415334026827 | MNA-420 DEC | K9303331 | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
39 | 05415334026810 | MNA-440 DEC | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
40 | 05415334025233 | NMS 1.xx | Nexxis Management Suite | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
41 | 05415334025011 | MNA-240 DEC | K9303275a | MNA-240 DEC V2 INC SFP+ | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
42 | 05415334002845 | MNA-440 ENC | K9303301X | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
43 | 05415334002838 | MNA-440 ENC | K9303301I | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
44 | 05415334002852 | Nexxis system | K9605022 | NEXXIS SYSTEM X670 CM US | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
45 | 05415334002821 | MNA-440 ENC | K9303301G | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
46 | 05415334002814 | MNA-440 ENC | K9303301F | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
47 | 05415334002807 | MNA-440 ENC | K9303301B | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
48 | 05415334002791 | MNA-420 ENC | K9303321X | MNA-420 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
49 | 05415334030220 | Nexxis | NEXXIS SYSTEM X620 CM V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
50 | 05415334030213 | Nexxis | NEXXIS SYSTEM X670 CM V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B334XD4P00 | 4.0 | XD | MIRADA MEDICAL LIMITED | ||
2 | B334XD3P60 | 3.6 | XD | MIRADA MEDICAL LIMITED | ||
3 | B334WORKFLOWBOX2P60 | 2.6 | Workflow Box | MIRADA MEDICAL LIMITED | ||
4 | B334WORKFLOWBOX2P40 | 2.4 | Workflow Box | MIRADA MEDICAL LIMITED | ||
5 | B334WORKFLOWBOX2P20 | 2.2 | Workflow Box | MIRADA MEDICAL LIMITED | ||
6 | B334WORKFLOWBOX2P00 | 2.0 | Workflow Box | MIRADA MEDICAL LIMITED | ||
7 | B334SY2P60 | 2.6 | Simplicit90Y | MIRADA MEDICAL LIMITED | ||
8 | B334SY2P40 | 2.4 | Simplicit90Y | MIRADA MEDICAL LIMITED | ||
9 | B334SY2P20 | 2.2 | Simplicit90Y | MIRADA MEDICAL LIMITED | ||
10 | B334SY2P00 | 2.0 | Simplicit90Y | MIRADA MEDICAL LIMITED | ||
11 | B334RTX1P80 | 1.8 | RTx | MIRADA MEDICAL LIMITED | ||
12 | B334RTX1P60 | 1.6 | RTx | MIRADA MEDICAL LIMITED | ||
13 | B334NMX4P40 | 4.4 | XD Nuclear Medicine | MIRADA MEDICAL LIMITED | ||
14 | B334NMX4P20 | 4.2 | XD Nuclear Medicine | MIRADA MEDICAL LIMITED | ||
15 | B334ALINE1P00 | 1.0 | Aline Ablation Intelligence | MIRADA MEDICAL LIMITED | ||
16 | B332VIVA0100 | ORS-VISU-VA01 | Vessel Analysis is a post-processing add-on module for ORS Visual that enables r Vessel Analysis is a post-processing add-on module for ORS Visual that enables radiologists, cardiologists, vascular surgeons, and interventionalists to quickly and confidently evaluate CT angiographic studies. Vessel Analysis provides stenosis calculations, aneurysm quantification, and stent and stent-graft planning of the aorta, carotid, and renal arteries in an easy-to-use, intuitive screen that can simplify the clinical task of planning endovascular procedures. Advanced functionality such as automated vessel finding acts as a baseline for accurate vessel measurements and permits rapid segmentation of vessels.ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware. | Vessel Analysis for ORS Visual | OBJECT RESEARCH SYSTEMS (ORS) INC | |
17 | B332VISU0105 | ORS-VISU-0105 | ORS Visual is a proprietary software application developed by Object Research Sy ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware. Available functions include DICOM communication, display of 2D images in orthogonal and oblique planes, computation and display of rendered 3D images and maximum intensity projections (MIPs), and 2D and 3D image measurements. The user interface follows typical clinical workflow patterns that include searching for patient data, reviewing and analyzing digital images, and reporting findings. The user controls these functions with normal mouse-click conventions, a system of context-based tools, and on-screen prompts. A standard layout for image display, navigation, and information is used throughout the application.ORS Visual also offers users two separate add-on modules to address specific vascular clinical functionalities: Vessel Analysis, an add-on solution for vascular analysis and stent-graft planning of CTA studies, and Autoplaque, a cardiac plaque and lesion quantification tool. | ORS Visual | OBJECT RESEARCH SYSTEMS (ORS) INC | |
18 | B332VIAP0100 | ORS-VISU-AP01 | Autoplaque is a post-processing add-on module for ORS Visual that provides autom Autoplaque is a post-processing add-on module for ORS Visual that provides automated quantification of calcified and non-calcified plaque lesions in coronary arteries from contrasted coronary CT angiographic studies for the evaluation of cardiovascular disease. Users can automatically segment the section of the coronary artery of interest, or manually input the centerline, to initiate a detailed and robust plaque lesion analysis routine. Analysis by Autoplaque provides biometric information that includes calcified plaque volume, non-calcified plaque volume with possible separation into low and high density non-calcified plaques, stenosis percentage, remodeling index, plaque length measurement, and proximal, distal, and stenosis diameters. If the Autoplaque add-on is used to analyze more than one coronary artery section, the additional parameters of total non-calcified plaque volume, total low density plaque volume, total calcified plaque volume, maximum remodeling index, maximum stenosis percentage, and the maximum plaque length will also be available.ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware. | Autoplaque for ORS Visual | OBJECT RESEARCH SYSTEMS (ORS) INC | |
19 | B319IBRADTECH20 | 2.0 | IB Rad Tech | IMAGING BIOMETRICS, LLC | ||
20 | B319IBRADTECH120 | 1.2 | IB Rad Tech | IMAGING BIOMETRICS, LLC | ||
21 | B319IBNEURO20 | 2.0 | IB Neuro | IMAGING BIOMETRICS, LLC | ||
22 | B319IBNEURO120 | 1.2 | IB Neuro | IMAGING BIOMETRICS, LLC | ||
23 | B319IBDIFFUSION20 | 2.0 | IB Diffusion | IMAGING BIOMETRICS, LLC | ||
24 | B319IBDIFFUSION12 | 1.2 | IB Diffusion | IMAGING BIOMETRICS, LLC | ||
25 | B319IBDELTASUITE20 | 2.0 | IB Delta Suite | IMAGING BIOMETRICS, LLC | ||
26 | B319IBDELTASUITE120 | 1.2 | IB Delta Suite | IMAGING BIOMETRICS, LLC | ||
27 | B319IBDCE20 | 2.0 | IB DCE | IMAGING BIOMETRICS, LLC | ||
28 | B319IBDCE120 | 1.2 | IB DCE | IMAGING BIOMETRICS, LLC | ||
29 | B319IBCLINIC20 | 2.0 | IB Clinic | IMAGING BIOMETRICS, LLC | ||
30 | B319IBCLINIC120 | 1.2 | IB Clinic | IMAGING BIOMETRICS, LLC | ||
31 | B269SWR00069MD0 | SWR-00069-MD | CuattroDR System Software | CuattroDR | CUATTRO MEDICAL | |
32 | B269SWR00021MD0 | SWR-00021-MD | CloudDR™ Medical System Software | CloudDR™ | CUATTRO MEDICAL | |
33 | B229S210011 | 1 | System 2100 | MATH RESOLUTIONS, LLC | ||
34 | B228INTELEPACS0 | INTELEPACS | INTELEPACS | LES SYSTÈMES MÉDICAUX INTELERAD INCORPORÉE | ||
35 | B209XP2X00 | 2.0 | V3D-Explorer is a software application used with advanced PC hardware for the di V3D-Explorer is a software application used with advanced PC hardware for the display and 3D visualization of DICOM 3.0 compliant medical images derived from CT, MRI, PET and SPECT scans. The linear, angular and volume measurement features provided in the software for the evaluation and quantification of organ, hard and soft tissues as well as internal organ structures for lesion, mass and other anomalies. It also supports interactive segmentation of any organ. | V3D-Explorer | VIATRONIX INCORPORATED | |
36 | B209VC4X1X2X330 | 4.1.2.33 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
37 | B209VC4X1X2X320 | 4.1.2.32 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
38 | B209VC4X1X2X110 | 4.1.2.11 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
39 | B209VC4X1X1X150 | 4.1.1.15 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
40 | B209VC4X0X3X40 | 4.0.3.4 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
41 | B209VC4X0X3X13F0 | 4.0.3.13 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
42 | B209VC4X0X0X44F0 | 4.0.0.44 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
43 | B209VC4X0X0X360 | 4.0.0.36 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
44 | B209VC3X3X3X10 | 3.3.3.1 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
45 | B209VA2X00 | 2.0 | V3D-Vascular is a software application used with advanced PC hardware for evalua V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system based on DICOM 3.0 compliant images from CT or MR scan. | V3D-Vascular | VIATRONIX INCORPORATED | |
46 | B198HMV11R70 | 11.7 | HMV11R7 | HealthMyne | HEALTHMYNE, INC. | |
47 | B198HMV11R50 | 11.5 | HealthMyne | HEALTHMYNE, INC. | ||
48 | B198HMV11R40 | 11.4 | HealthMyne | HEALTHMYNE, INC. | ||
49 | B198HMV11R30 | 11.3 | HealthMyne | HEALTHMYNE, INC. | ||
50 | B198HMV11R1PK0 | 11.1 | HealthMyne | HEALTHMYNE, INC. |