| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 17540262130089 | 1.0.7 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
| 2 | 17540262130072 | 1.0.6 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
| 3 | 17540262130065 | 1.0.5 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
| 4 | 17540262130058 | 1.0.4 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
| 5 | 17540262130041 | 1.0.3 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network Viewer | ||
| 6 | 17540262130034 | 1.0.2 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
| 7 | 17540262130027 | 1.0.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network Viewer | ||
| 8 | 17540262130010 | 1.0.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network Viewer | ||
| 9 | 17540262150018 | 1.0.0 | QIH | Automated Radiological Image Processing Software | 2 | Change Healthcare Anatomical AI™ | ||
| 10 | 17540262140026 | 25.0 | LLZ | System, Image Processing, Radiological | 2 | Nucleus.io | ||
| 11 | 17540262140019 | 24 | LLZ | System, Image Processing, Radiological | 2 | Nucleus.io | ||
| 12 | 17540262040029 | 2.2.0 | LLZ | System, Image Processing, Radiological | 2 | Conserus Enterprise Viewer | ||
| 13 | 17540262040012 | 2.1 | LLZ | System, Image Processing, Radiological | 2 | Conserus Enterprise Viewer | ||
| 14 | 17540262130126 | 1.0.11 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
| 15 | 17540262130119 | 1.0.10 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
| 16 | 17540262130102 | 1.0.9 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
| 17 | 17540262130096 | 1.0.8 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
| 18 | 17540262110050 | 14.3.2 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
| 19 | 17540262110043 | 14.3 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
| 20 | 17540262110036 | 14.2 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
| 21 | 17540262160055 | 1.0.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
| 22 | 17540262160048 | 1.1.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
| 23 | 17540262160031 | 1.0.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
| 24 | 17540262160024 | 0.7.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
| 25 | 17540262160017 | 0.6.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
| 26 | 17540262020021 | 12.4 | LLZ | System, Image Processing, Radiological | 2 | McKesson Radiology | ||
| 27 | 17540262020014 | 12.3 | LLZ | System, Image Processing, Radiological | 2 | McKesson Radiology | ||
| 28 | 17540262010046 | 2.1.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Viewer | ||
| 29 | 17540262010039 | 2.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Viewer | ||
| 30 | 17540262010022 | 2.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Viewer | ||
| 31 | 17540262100044 | 14.3 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
| 32 | 17540262100037 | 14.2 | MWI,DQK | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms),Compute Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms),Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology Hemo | ||
| 33 | 17540262110104 | 15.0.1 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
| 34 | 17540262110098 | 15.0 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
| 35 | 17540262100105 | 15.0.1 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
| 36 | 17540262100099 | 15.0 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
| 37 | 17540262100051 | 14.3.2 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
| 38 | 17540262090109 | 15.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology | ||
| 39 | 17540262090055 | 14.3.2 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology | ||
| 40 | 17540262090048 | 14.3 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology | ||
| 41 | 17540262030037 | 14.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Radiology Solutions | ||
| 42 | 17540262030020 | 14.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Radiology Solutions | ||
| 43 | 17540262030013 | 12.4.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Radiology Solutions | ||
| 44 | 17540262090031 | 14.2 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B319IBRADTECH20 | 2.0 | IB Rad Tech | IMAGING BIOMETRICS, LLC | ||
| 2 | B319IBRADTECH120 | 1.2 | IB Rad Tech | IMAGING BIOMETRICS, LLC | ||
| 3 | B319IBNEURO20 | 2.0 | IB Neuro | IMAGING BIOMETRICS, LLC | ||
| 4 | B319IBNEURO120 | 1.2 | IB Neuro | IMAGING BIOMETRICS, LLC | ||
| 5 | B319IBDIFFUSION20 | 2.0 | IB Diffusion | IMAGING BIOMETRICS, LLC | ||
| 6 | B319IBDIFFUSION12 | 1.2 | IB Diffusion | IMAGING BIOMETRICS, LLC | ||
| 7 | B319IBDELTASUITE20 | 2.0 | IB Delta Suite | IMAGING BIOMETRICS, LLC | ||
| 8 | B319IBDELTASUITE120 | 1.2 | IB Delta Suite | IMAGING BIOMETRICS, LLC | ||
| 9 | B319IBDCE20 | 2.0 | IB DCE | IMAGING BIOMETRICS, LLC | ||
| 10 | B319IBDCE120 | 1.2 | IB DCE | IMAGING BIOMETRICS, LLC | ||
| 11 | B319IBCLINIC20 | 2.0 | IB Clinic | IMAGING BIOMETRICS, LLC | ||
| 12 | B319IBCLINIC120 | 1.2 | IB Clinic | IMAGING BIOMETRICS, LLC | ||
| 13 | B269SWR00069MD0 | SWR-00069-MD | CuattroDR System Software | CuattroDR | CUATTRO MEDICAL | |
| 14 | B269SWR00021MD0 | SWR-00021-MD | CloudDR™ Medical System Software | CloudDR™ | CUATTRO MEDICAL | |
| 15 | B229S210011 | 1 | System 2100 | MATH RESOLUTIONS, LLC | ||
| 16 | B228INTELEPACS0 | INTELEPACS | INTELEPACS | LES SYSTÈMES MÉDICAUX INTELERAD INCORPORÉE | ||
| 17 | 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 | |
| 18 | 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 | |
| 19 | 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 | |
| 20 | 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 | |
| 21 | 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 | |
| 22 | 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 | |
| 23 | 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 | |
| 24 | 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 | |
| 25 | 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 | |
| 26 | 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 | |
| 27 | 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 | |
| 28 | B198HMV11R70 | 11.7 | HMV11R7 | HealthMyne | HEALTHMYNE, INC. | |
| 29 | B198HMV11R50 | 11.5 | HealthMyne | HEALTHMYNE, INC. | ||
| 30 | B198HMV11R40 | 11.4 | HealthMyne | HEALTHMYNE, INC. | ||
| 31 | B198HMV11R30 | 11.3 | HealthMyne | HEALTHMYNE, INC. | ||
| 32 | B198HMV11R1PK0 | 11.1 | HealthMyne | HEALTHMYNE, INC. | ||
| 33 | B198HM01220 | 12.2 | HealthMyne | HEALTHMYNE, INC. | ||
| 34 | B198HM01210 | 12.1 | HealthMyne | HEALTHMYNE, INC. | ||
| 35 | B198HM0120 | 12.0 | HMV12 | HealthMyne | HEALTHMYNE, INC. | |
| 36 | B198HM01160 | 11.6 | HealthMyne | HEALTHMYNE, INC. | ||
| 37 | B198HM0110 | 11.0 | HealthMyne | HEALTHMYNE, INC. | ||
| 38 | B198HM0102 | 10.2 | HealthMyne | HEALTHMYNE, INC. | ||
| 39 | B198HM0101 | 10.1 | HealthMyne | HEALTHMYNE, INC. | ||
| 40 | B198HM0100 | 10.0 | HealthMyne | HEALTHMYNE, INC. | ||
| 41 | B198HM0090 | 9.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 42 | B198HM0083 | 8.3 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 43 | B198HM0082 | 8.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 44 | B198HM0081 | 8.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 45 | B198HM0080 | 8.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 46 | B198HM0071 | 7.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 47 | B198HM0070 | 7.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 48 | B198HM0063 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 49 | B198HM0062 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 50 | B198HM0061 | 6.1 | HealthMyne QIDS | HEALTHMYNE, INC. |