| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04996005103562 | CCL214 | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 2 | 04996005103555 | CCL550i2/N | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 3 | 04996005103531 | CCL550i2/F | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 4 | 04996005103524 | CCL550i2/AR | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 5 | 04996005103463 | CCL244/AR | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 6 | 04996005103456 | CCL220/AR | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 7 | 04996005103449 | CCL210 | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 8 | 04996005103432 | ME205 | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 9 | 04996005103128 | CCL650i2/AR | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 10 | 04996005103111 | CCL650i2/N | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 11 | 04996005103067 | MS25i2/F | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 12 | 04996005103050 | MS25i2/AR | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 13 | 04996005103043 | MS25i2/N | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 14 | 04996005103036 | MS35i2/F | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 15 | 04996005103029 | MS35i2/AR | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 16 | 04996005103012 | MS35i2/N | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 17 | 04996005102961 | CCL258i2/F | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 18 | 04996005102954 | CCL258i2/AR | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 19 | 04996005102947 | CCL258i2/N | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 20 | 04996005102930 | CCL358i2/F | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 21 | 04996005102923 | CCL358i2/AR | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 22 | 04996005102916 | CCL358i2/N | LLZ | System, Image Processing, Radiological | 2 | TOTOKU | ||
| 23 | 04996005102909 | MS55i2/F | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 24 | 04996005102893 | MS55i2/AR | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 25 | 04996005102886 | MS55i2/N | PGY | Display, Diagnostic Radiology | 2 | TOTOKU | ||
| 26 | 00046838076541 | MS25i2/F | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 27 | 00046838076534 | MS35i2/AR | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 28 | 00046838081941 | MS-S300 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 29 | 00046838081033 | MS-S500 | MS-S500BG2 | PGY | Display, Diagnostic Radiology | 2 | JVC | |
| 30 | 00046838081026 | CL-S500 | CL-S500BG2 | PGY | Display, Diagnostic Radiology | 2 | JVC | |
| 31 | 00046838079979 | MS-S500 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 32 | 00046838079962 | CL-S500 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 33 | 00046838078897 | CL-R211 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 34 | 00046838078880 | CL-S200 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 35 | 00046838077531 | CL-S300 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 36 | 00046838077524 | CL-S300 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 37 | 00046838076626 | CCL214 | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 38 | 00046838076619 | CCL650i2/AR | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 39 | 00046838076602 | CCL650i2/N | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 40 | 00046838076596 | CCL258i2/F | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 41 | 00046838076589 | CCL258i2/AR | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 42 | 00046838076572 | CCL258i2/N | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 43 | 00046838076565 | MS25i2/AR | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 44 | 00046838076558 | MS25i2/N | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 45 | 00046838076510 | MS35i2/F | LLZ | System, Image Processing, Radiological | 2 | JVC | ||
| 46 | 00046838076435 | MS55i2 plus | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 47 | 00046838076411 | MS55i2 plus | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 48 | 00046838076381 | CCL550i2/F | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 49 | 00046838076374 | CCL550i2/N | PGY | Display, Diagnostic Radiology | 2 | JVC | ||
| 50 | 00046838076367 | CCL358i2/F | LLZ | System, Image Processing, Radiological | 2 | JVC |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | SURGICALAR0 | 1.1.0.0 | SurgicalAR | MEDIVIS, INC | ||
| 2 | 17540266000029 | 4.6 | HeartPro is a web-accessible, self-contained image analysis software application HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. | HeartPro | MEDVOXEL DIAGNOSTICS INC | |
| 3 | 17540266000012 | 4.5 | HeartPro is a web-accessible, self-contained image analysis software application HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. | HeartPro | MEDVOXEL DIAGNOSTICS INC | |
| 4 | 17540262160055 | 1.0.1 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
| 5 | 17540262160048 | 1.1.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
| 6 | 17540262160031 | 1.0.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
| 7 | 17540262160024 | 0.7.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
| 8 | 17540262160017 | 0.6.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
| 9 | 17540262140026 | 25.0 | Nucleus.io | CHANGE HEALTHCARE CANADA COMPANY | ||
| 10 | 17540262140019 | 24 | Nucleus.io | CHANGE HEALTHCARE CANADA COMPANY | ||
| 11 | 17540262130126 | 1.0.11 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 12 | 17540262130119 | 1.0.10 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 13 | 17540262130102 | 1.0.9 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 14 | 17540262130096 | 1.0.8 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 15 | 17540262130089 | 1.0.7 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 16 | 17540262130072 | 1.0.6 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 17 | 17540262130065 | 1.0.5 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 18 | 17540262130058 | 1.0.4 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 19 | 17540262130041 | 1.0.3 | Change Healthcare Enterprise Imaging Network Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 20 | 17540262130034 | 1.0.2 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 21 | 17540262130027 | 1.0.1 | Change Healthcare Enterprise Imaging Network Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 22 | 17540262130010 | 1.0.0 | Change Healthcare Enterprise Imaging Network Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 23 | 17540262090116 | 15.0.1 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
| 24 | 17540262090109 | 15.0 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
| 25 | 17540262090055 | 14.3.2 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
| 26 | 17540262090048 | 14.3 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
| 27 | 17540262090031 | 14.2 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
| 28 | 17540262090024 | 14.1.1 | Change Healthcare Cardiology | CHANGE HEALTHCARE ISRAEL LTD | ||
| 29 | 17540262090017 | 14.1 | Change Healthcare Cardiology | CHANGE HEALTHCARE ISRAEL LTD | ||
| 30 | 17540262040029 | 2.2.0 | Conserus Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 31 | 17540262040012 | 2.1 | Conserus Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 32 | 17540262030037 | 14.1 | Change Healthcare Radiology Solutions | CHANGE HEALTHCARE CANADA COMPANY | ||
| 33 | 17540262030020 | 14.0 | Change Healthcare Radiology Solutions | CHANGE HEALTHCARE CANADA COMPANY | ||
| 34 | 17540262030013 | 12.4.1 | Change Healthcare Radiology Solutions | CHANGE HEALTHCARE CANADA COMPANY | ||
| 35 | 17540262020021 | 12.4 | McKesson Radiology | CHANGE HEALTHCARE CANADA COMPANY | ||
| 36 | 17540262020014 | 12.3 | McKesson Radiology | CHANGE HEALTHCARE CANADA COMPANY | ||
| 37 | 17540262010046 | 2.1.1 | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 38 | 17540262010039 | 2.1 | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 39 | 17540262010022 | 2.0 | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
| 40 | 15420045512634 | Unifi Workspace V1.0 | Unifi Workspace | HOLOGIC, INC. | ||
| 41 | 15420045511859 | Unifi Workspace V1.0 | Unifi Workspace | HOLOGIC, INC. | ||
| 42 | 15420045510319 | 2.2 | Breast Density Assessment Software | Quantra | HOLOGIC, INC. | |
| 43 | 15420045504806 | 1.0 | DigitalNow HD | DigitalNow HD | HOLOGIC, INC. | |
| 44 | 15420045504790 | 2.1 | Breast Density Assessment | Quantra | HOLOGIC, INC. | |
| 45 | 15420045504691 | PRIMA | PRIMA | HOLOGIC, INC. | ||
| 46 | 15420045504684 | MultiView | MULTIVIEW | HOLOGIC, INC. | ||
| 47 | 15420045504523 | SecurView DX | SecurView Diagnostic Workstation | HOLOGIC, INC. | ||
| 48 | 14573443600029 | Ver.14.0.4.1 | ZedView | LEXI CO., LTD. | ||
| 49 | 14260495880331 | 3.3.0 | The product mint Lesion helps qualified radiologists with the image-based diagno The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients. mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate. mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)). mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications. | mintLesion® | MINT MEDICAL GMBH | |
| 50 | M722Z19154V191210 | 1.0.2 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. |