| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00884838074781 | 4.x | 837507 | IntelliSpace PACS is an image management system intended to be used by trained p IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. | LLZ | System, image processing, radiological | 2 | IntelliSpace PACS |
| 2 | 00884838091740 | 4.x | 836344 | IntelliSpace Radiology Software (client) is a software package intended to be us IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography. | LLZ | System, image processing, radiological | 2 | IntelliSpace Radiology |
| 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 |