| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08056304454348 | 10.2 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 2 | 08056304453471 | 2.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS IntraVascular | ||
| 3 | 08056304451187 | 1.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS IntraVascular | ||
| 4 | 08056304454249 | 10.1 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 5 | 08056304454256 | 5.2 | LLZ | System, Image Processing, Radiological | 2 | CAAS MR Solution | ||
| 6 | 08056304454669 | 10.3 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 7 | 08056304454461 | 8.5 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 8 | 08056304454331 | 8.4 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 9 | 08056304454072 | 10.0 | Development ongoing | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | |
| 10 | 08056304454065 | 2.1 | LLZ | System, Image Processing, Radiological | 2 | CAAS IntraVascular | ||
| 11 | 08056304454058 | 8.2 | Development ongoing | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | |
| 12 | 08056304454003 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 13 | 08056304453839 | 9.1 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 14 | 08056304453778 | 9.0 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 15 | 08056304453761 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 16 | 08056304453495 | 6.1 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 17 | 08056304453488 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 18 | 08056304453440 | 7.5 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 19 | 08056304453426 | 4.3 | LLZ | System, Image Processing, Radiological | 2 | CAAS MRV | ||
| 20 | 08056304453099 | 7.4 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 21 | 08056304453044 | 4.2 | LLZ | System, Image Processing, Radiological | 2 | CAAS MRV | ||
| 22 | 08056304451224 | 5.0 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 23 | 08056304451217 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | 3mensio Workstation | ||
| 24 | 08056304451200 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 25 | 08056304451194 | 7.1 | LLZ | System, Image Processing, Radiological | 2 | CAAS Workstation | ||
| 26 | 08056304451163 | 3.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS MRV | ||
| 27 | 08056304451170 | 1.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS MR Flow | ||
| 28 | 08056304453433 | 2.0 | LLZ,IZI | System, Image Processing, Radiological,System, X-Ray, Angiographic | 2 | CAAS MR 4D Flow | ||
| 29 | 08056304453051 | 1.1 | LLZ,IZI | System, Image Processing, Radiological,System, X-Ray, Angiographic | 2 | CAAS MR 4D Flow | ||
| 30 | 08056304451132 | 5.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS 5 | ||
| 31 | 08056304454270 | 2.1 | LLZ | System, Image Processing, Radiological | 2 | CAAS A-Valve | ||
| 32 | 08056304454041 | 5.1 | Development ongoing | LLZ | System, Image Processing, Radiological | 2 | CAAS MR Solutions | |
| 33 | 08056304453969 | 5.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS MR Solutions | ||
| 34 | 08056304451156 | 2.0 | LLZ | System, Image Processing, Radiological | 2 | CAAS A-Valve | ||
| 35 | 08056304451149 | 1.0 | LLZ,IZI | System, Image Processing, Radiological,System, X-Ray, Angiographic | 2 | CAAS A-Valve |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 07090045490365 | P001000-04 | P001000-04 | Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0) | Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0) | BIIM ULTRASOUND AS |
| 2 | 07090045490358 | P001253 | P001253 | Battery Charger AU, Biim Ultrasound | Battery Charger AU, Biim Ultrasound | BIIM ULTRASOUND AS |
| 3 | 07090045490334 | P001425 | P001425 | Biim Android App, P2.0 | Biim Android App, P2.0 | BIIM ULTRASOUND AS |
| 4 | 07090045490327 | P001424 | P001424 | Biim iOS App, P2.0 | Biim iOS App, P2.0 | BIIM ULTRASOUND AS |
| 5 | 07090045490310 | P001418 | P001418 | Biim Android App, P1.3.2 | Biim Android App, P1.3.2 | BIIM ULTRASOUND AS |
| 6 | 07090045490303 | P001417 | P001417 | Biim iOS App, P1.3.2 | Biim iOS App, P1.3.2 | BIIM ULTRASOUND AS |
| 7 | 07090045490273 | P001197 | P001197 | Battery Charger UK, Biim Ultrasound | Battery Charger UK, Biim Ultrasound | BIIM ULTRASOUND AS |
| 8 | 07090045490266 | P001198 | P001198 | Battery Charger EU, Biim Ultrasound | Battery Charger EU, Biim Ultrasound | BIIM ULTRASOUND AS |
| 9 | 07090045490235 | P001403 | P001403 | Biim Android App, P1.3.1 | Biim Android App, P1.3.1 | BIIM ULTRASOUND AS |
| 10 | 07090045490228 | P001402 | P001402 | Biim iOS App, P1.3.1 | Biim iOS App, P1.3.1 | BIIM ULTRASOUND AS |
| 11 | 07090045490198 | P001228 | P001228 | Biim Android App, P1.3 | Biim Android App, P1.3 | BIIM ULTRASOUND AS |
| 12 | 07090045490181 | P001227 | P001227 | Biim iOS App, P1.3 | Biim iOS App, P1.3 | BIIM ULTRASOUND AS |
| 13 | 07090045490150 | P001158 | P001158 | Biim Android App, P1.2 | Biim Android App, P1.2 | BIIM ULTRASOUND AS |
| 14 | 07090045490143 | P001157 | P001157 | Biim iOS App, P1.2 | Biim iOS App, P1.2 | BIIM ULTRASOUND AS |
| 15 | 07090045490129 | P001160 | P001160 | Adapter Bracket, Biim Ultrasound | Adapter Bracket, Biim Ultrasound | BIIM ULTRASOUND AS |
| 16 | 07090045490099 | P001052 | P001052 | Battery Charger, Biim Ultrasound | Battery Charger, Biim Ultrasound | BIIM ULTRASOUND AS |
| 17 | 07090045490068 | P001175 | P001175 | Probe Holder, (V1) Biim Ultrasound | Probe Holder, (V1) Biim Ultrasound | BIIM ULTRASOUND AS |
| 18 | 07090045490051 | P001137 | P001137 | Probe holder, (V2) Biim Ultrasound | Probe holder, (V2) Biim Ultrasound | BIIM ULTRASOUND AS |
| 19 | 07090045490037 | P001050 | P001050 | Battery, Biim Ultrasound | Battery, Biim Ultrasound | BIIM ULTRASOUND AS |
| 20 | 07090045490020 | P001118 | P001118 | Biim Android App, P1.1 | Biim Android App, P1.1 | BIIM ULTRASOUND AS |
| 21 | 07090045490013 | P001117 | P001117 | Biim iOS App, P1.1 | Biim iOS App, P1.1 | BIIM ULTRASOUND AS |
| 22 | 07090045490006 | P001000 | P001000 | Biim Ultrasound L12-4 Linear Array Transducer | Biim Ultrasound L12-4 Linear Array Transducer | BIIM ULTRASOUND AS |
| 23 | 07090042059046 | 1.1 | nordicDSC | NORDICNEUROLAB AS | ||
| 24 | 07090042059015 | 2.3 | The nordicBrainEx Software is a post-processing application for dynamic MRI data The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focuson ease of use and high performance on a standard Windows workstation. The software providescomprehensive functionality for dynamic image analysis and visualization of MRI data, where signalchanges over time are analyzed to determine various modality dependent functional parameters. Thefollowing algorithms provide the main functional analyses of the application.- BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in thehuman brain in areas with altered blood-flow resulting from neuronal activity.- DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis ofdiffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusionto display the white matter structure in the brain.- DSC: Calculations of perfusion related parameters that provide information about the bloodvessel structure and characteristics. Examples of such maps are blood volume, blood flow, timeto peak, mean transit time and leakage.In addition to these specific functional analyses, the application also provides general visualization tools,a database for data handling, and a reporting feature. This is to ensure that the workflow of theapplication is optimized to ensure efficiency and high throughput in a clinical environment. | nordicBrainEx | NORDICNEUROLAB AS | |
| 25 | 06971576834150 | uWS-CT | uWS | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | ||
| 26 | 06971576834143 | uWS-MR | uWS | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | ||
| 27 | 06971576834037 | uWS-MI | PET/CT Image Post-Processing Software | uWS | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 28 | 06971576834020 | uWS-CT | CT Image Post-Processing Software | uWS | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 29 | 06971576834013 | uWS-MR | MR Image Post-Processing Software | uWS | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 30 | 06970901070010 | V2.0 | miPlatform | HINACOM SOFTWARE AND TECHNOLOGY, LTD. | ||
| 31 | 06970167440077 | NeuViz Prime | NeuViz Prime Multi-Slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 32 | 06938396423025 | SR-2300S | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 33 | 06938396423018 | SR-2300 | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 34 | 06938396410063 | SR-1000S | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 35 | 06938396410049 | SR-1000 | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 36 | 06938396400446 | SR-2100S | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 37 | 06938396400439 | SR-2100 | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 38 | 06938396400422 | SR-1100S | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 39 | 06938396400415 | SR-1100 | Portable DR Imaging System | SIUI | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | |
| 40 | 06430070841021 | 2.0.X | https://www.combinostics.com/cmri/ | cNeuro cMRI | COMBINOSTICS OY | |
| 41 | 06430035420254 | 4 | Planmeca Romexis is a modular imaging software for dental and medical use, | Planmeca Romexis | PLANMECA OY | |
| 42 | 06429810209023 | Bonelogic 2 | Bonelogic | DISIOR OY | ||
| 43 | 05902768365306 | 2016-1 | IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the placement of one or more implants based on an imported CBCT scan and optionally aligned with a loaded 3D surface scan. The implants are provided by a secured implant library. In addition Virtual Crowns can be used for optimized implant positioning under the esthetical aspect. Further a surgical guide for a guided surgery can be designed and exported for 3rd party fabrication based on the approved implant position. The use of the software requires to have the necessary expertise in implant dentistry.The IMPLANT STUDIO IPGS system must be operated by trained dental practitioners and dental technicians who are skilled in implant dentistry.The IMPLANT STUDIO IPGS software is to be used in general dentist clinics and dental laboratories. | 3Shape Implant Studio | 3SHAPE MEDICAL A/S | |
| 44 | 05902729753265 | 2.17.3 (R1.2) | Dental treatment application software | Implant Studio | 3SHAPE MEDICAL A/S | |
| 45 | 05902729750448 | 2017-1 | Dental treatment application software | Implant Studio | 3SHAPE MEDICAL A/S | |
| 46 | 05902729750455 | 2017-1 | Dental treatment application software | CT Preparation | 3SHAPE MEDICAL A/S | |
| 47 | 05700002173614 | v.1. | RBknee | RADIOBOTICS APS | ||
| 48 | 05700002060457 | 2.5 | Neuroreader | BRAINREADER APS | ||
| 49 | 05700002060440 | 2.4 | Neuroreader | BRAINREADER APS | ||
| 50 | 05700002060433 | 2.3 | Neuroreader | BRAINREADER APS |