No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00628011382153 | 1.5.0 | Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). | LLZ | System, Image Processing, Radiological | 2 | Limbus Contour | |
2 | 00628011382146 | 1.4.0 | Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). | LLZ | System, Image Processing, Radiological | 2 | Limbus Contour |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08624310003203 | AVM3 | Arterys Viewer | ARTERYS INC. | ||
2 | 08624310003104 | CVM2 | Arterys Cardio DL | ARTERYS INC. | ||
3 | 08606102809033 | Avanse DR | Visaris Avanse® is a digital radiography imaging, control and management softwar Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements. | Visaris Avanse | VISARIS DOO | |
4 | 08437021722055 | v2.9 | ADAS 3D | ADAS3D MEDICAL S.L. | ||
5 | 08437021722048 | V2.6 | ADAS 3D | ADAS3D MEDICAL S.L. | ||
6 | 08437021722031 | V2.8 | ADAS 3D | ADAS3D MEDICAL S.L. | ||
7 | 08437021722024 | V2.10 | ADAS 3D | ADAS3D MEDICAL S.L. | ||
8 | 08056477300008 | ComPACS | MediMatic | MEDIMATIC SRL | ||
9 | 08056304454669 | 10.3 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
10 | 08056304454461 | 8.5 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
11 | 08056304454348 | 10.2 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
12 | 08056304454331 | 8.4 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
13 | 08056304454270 | 2.1 | CAAS A-Valve | PIE MEDICAL IMAGING B.V. | ||
14 | 08056304454256 | 5.2 | CAAS MR Solution | PIE MEDICAL IMAGING B.V. | ||
15 | 08056304454249 | 10.1 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
16 | 08056304454225 | 9.2 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
17 | 08056304454072 | 10.0 | Development ongoing | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | |
18 | 08056304454065 | 2.1 | CAAS IntraVascular | PIE MEDICAL IMAGING B.V. | ||
19 | 08056304454058 | 8.2 | Development ongoing | CAAS Workstation | PIE MEDICAL IMAGING B.V. | |
20 | 08056304454041 | 5.1 | Development ongoing | CAAS MR Solutions | PIE MEDICAL IMAGING B.V. | |
21 | 08056304454003 | 8.1 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
22 | 08056304453969 | 5.0 | CAAS MR Solutions | PIE MEDICAL IMAGING B.V. | ||
23 | 08056304453839 | 9.1 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
24 | 08056304453778 | 9.0 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
25 | 08056304453761 | 8.0 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
26 | 08056304453495 | 6.1 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
27 | 08056304453488 | 8.1 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
28 | 08056304453471 | 2.0 | CAAS IntraVascular | PIE MEDICAL IMAGING B.V. | ||
29 | 08056304453440 | 7.5 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
30 | 08056304453433 | 2.0 | CAAS MR 4D Flow | PIE MEDICAL IMAGING B.V. | ||
31 | 08056304453426 | 4.3 | CAAS MRV | PIE MEDICAL IMAGING B.V. | ||
32 | 08056304453099 | 7.4 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
33 | 08056304453051 | 1.1 | CAAS MR 4D Flow | PIE MEDICAL IMAGING B.V. | ||
34 | 08056304453044 | 4.2 | CAAS MRV | PIE MEDICAL IMAGING B.V. | ||
35 | 08056304451224 | 5.0 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
36 | 08056304451217 | 8.0 | 3mensio Workstation | PIE MEDICAL IMAGING B.V. | ||
37 | 08056304451200 | 7.2 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
38 | 08056304451194 | 7.1 | CAAS Workstation | PIE MEDICAL IMAGING B.V. | ||
39 | 08056304451187 | 1.0 | CAAS IntraVascular | PIE MEDICAL IMAGING B.V. | ||
40 | 08056304451170 | 1.0 | CAAS MR Flow | PIE MEDICAL IMAGING B.V. | ||
41 | 08056304451163 | 3.0 | CAAS MRV | PIE MEDICAL IMAGING B.V. | ||
42 | 08056304451156 | 2.0 | CAAS A-Valve | PIE MEDICAL IMAGING B.V. | ||
43 | 08056304451149 | 1.0 | CAAS A-Valve | PIE MEDICAL IMAGING B.V. | ||
44 | 08056304451132 | 5.0 | CAAS 5 | PIE MEDICAL IMAGING B.V. | ||
45 | 08056304450029 | 101002000 | G-scan Brio | ESAOTE SPA | ||
46 | 08050038830058 | RealGUIDE CAD+ | Full integrated planning, guide design and prosthesis modelling | 3DIEMME RealGUIDE | 3DIEMME SRL | |
47 | 08050038830041 | RealGUIDE CAD | Prosthesis modelling (stand-alone) | 3DIEMME RealGUIDE | 3DIEMME SRL | |
48 | 08050038830034 | RealGUIDE START | 3D diagnosis and communication module | 3DIEMME RealGUIDE | 3DIEMME SRL | |
49 | 08050038830027 | RealGUIDE DESIGN | Surgical guides modelling | 3DIEMME RealGUIDE | 3DIEMME SRL | |
50 | 08050038830010 | RealGUIDE PRO | Implants planning | 3DIEMME RealGUIDE | 3DIEMME SRL |