| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00884838061354 | 989605412062 | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Transducer D5CWC | ||
| 2 | 00884838061453 | 989605415032 | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Transducer 3D9-3v | ||
| 3 | 00884838067523 | 989605420183 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer S8-3t | ||
| 4 | 00884838067516 | 989605391083 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer L15-7io | ||
| 5 | 00884838108479 | 795123 | IYO,IYN,ITX | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultras System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | Lumify Diamond Select | ||
| 6 | 00884838108455 | 795005 | IYO,IYN,ITX | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultras System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | Lumify System | ||
| 7 | 00884838086623 | Release 3.8.5 | LLZ | System, image processing, radiological | 2 | Q-Station | ||
| 8 | 00884838074194 | 989605457831 | ITX | Transducer, ultrasonic, diagnostic | 2 | X8-2ti Transducer | ||
| 9 | 00884838068001 | 989605361403 | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Transducer S3-1 | ||
| 10 | 00884838065352 | 989605440662 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer 5.0 CW | ||
| 11 | 00884838061538 | 989605395612 | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Transducer C9-3io | ||
| 12 | 00884838067974 | 989605408173 | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer L12-5 | ||
| 13 | 00884838024649 | 21422A | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer PA4-2 | ||
| 14 | 00884838067608 | 989605440732 | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Transducer S3-1 | ||
| 15 | 00884838061507 | 989605391092 | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Transducer C9-2 | ||
| 16 | 00884838061392 | 989605389252 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer C9-4v | ||
| 17 | 00884838107724 | 453561998453 | ITX,IYN | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Lumify Power Module | ||
| 18 | 00884838113848 | 795118 | 9.X | IYN,IYO,ITX,OBJ,QIH | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Catheter, Ultrasound, Intravascular,Automated Radiological Image Processing Software | 2 | Affiniti 50 Ultrasound Circular Edition | |
| 19 | 00884838113831 | 795118 | Software Version 7.X | IYN,IYO,ITX,OBJ,QIH | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Catheter, Ultrasound, Intravascular,Automated Radiological Image Processing Software | 2 | Affiniti 50 Ultrasound Circular Edition | |
| 20 | 00884838107748 | 795125 | IYN,IYO,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | EPIQ Elite Diamond Select Ultrasound System | ||
| 21 | 00884838107533 | 795232 | LLZ,IYN,IYO,ITX,OBJ,QIH | System, Image Processing, Radiological,System, Imaging, Pulsed Doppler, Ultrason System, Image Processing, Radiological,System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Catheter, Ultrasound, Intravascular,Automated Radiological Image Processing Software | 2 | EPIQ CVxi Ultrasound System | ||
| 22 | 00884838107465 | 795120 | LLZ,IYN,IYO,ITX,OBJ,QIH | System, Image Processing, Radiological,System, Imaging, Pulsed Doppler, Ultrason System, Image Processing, Radiological,System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Catheter, Ultrasound, Intravascular,Automated Radiological Image Processing Software | 2 | EPIQ 5 Diamond Select Ultrasound System | ||
| 23 | 00884838103603 | 989606720441 | Software Revision 15.5 | QIH | Automated Radiological Image Processing Software | 2 | QLAB Advanced Quantification Software | |
| 24 | 00884838102606 | 989606717071 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | V9-2 Ultrasound Transducer | ||
| 25 | 00884838099432 | 989606710361 | JAK,LLZ,IYO | System, X-Ray, Tomography, Computed,System, Image Processing, Radiological,Syste System, X-Ray, Tomography, Computed,System, Image Processing, Radiological,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Percunav Planar Field Generator with Stand | ||
| 26 | 00884838097858 | 795120 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | EPIQ 5 DIAMOND SELECT SYSTEM | ||
| 27 | 00884838098183 | 795007 | IYN,IYO,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | LUMIFY RUGGED SYSTEM BUNDLE | ||
| 28 | 00884838097872 | 795201 | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | EPIQ 7C ULTRASOUND SYSTEM | ||
| 29 | 00884838091672 | 989605496481 | LLZ | System, image processing, radiological | 2 | QLAB Advanced Quantification Software | ||
| 30 | 00884838088160 | 989605486021 | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | mC7-2 | ||
| 31 | 00884838084322 | 989605465051 | LLZ | System, image processing, radiological | 2 | QLAB Advanced Quantification Software | ||
| 32 | 00884838070813 | 989605456291 | ITX | Transducer, ultrasonic, diagnostic | 2 | Transducer eL18-4 | ||
| 33 | 00884838068087 | 989605361414 | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer S4 | ||
| 34 | 00884838068032 | 989605430232 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer C8-4V | ||
| 35 | 00884838067943 | 989605371713 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Transducer C5-2 PUC | ||
| 36 | 00884838067929 | 989605361963 | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Transducer S8-3 | ||
| 37 | 00884838067875 | 989605418972 | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer C9-4v | ||
| 38 | 00884838067806 | 989605361882 | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Transducer S8-3 | ||
| 39 | 00884838067622 | 989605440752 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Transducer S8-3 | ||
| 40 | 00884838064713 | 989605449841 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Lumify Ultrasound System | ||
| 41 | 00884838064553 | 989605450081 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | V6-2 transducer | ||
| 42 | 00884838061811 | 989605360974 | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer V8-4 | ||
| 43 | 00884838040120 | 989605424402 | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | CX Cart | ||
| 44 | 00884838067561 | 989605440682 | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Transducer S5-1 | ||
| 45 | 00884838061637 | 989605412082 | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Transducer S5-1 | ||
| 46 | 00884838061613 | 989605412042 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer C5-1 | ||
| 47 | 00884838061545 | 989605395622 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Transducer 3D9-3v | ||
| 48 | 00884838067950 | 989605359593 | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Transducer C6-3 | ||
| 49 | 00884838081109 | 989605463921 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Transducer S5-1 | ||
| 50 | 00884838114470 | 795186 | Software Version 6.X | IYN,IYO,ITX,OBJ,QIH | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Catheter, Ultrasound, Intravascular,Automated Radiological Image Processing Software | 2 | Affiniti 70C Diagnostic Ultrasound System |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04540217011469 | 502-24400-12 | DAR-8000i | SHIMADZU CORPORATION | ||
| 2 | 04540217011452 | 502-24400-11 | DAR-8000i | SHIMADZU CORPORATION | ||
| 3 | 04260648620022 | 2021 (Build 1920) | Ashvins | MEDICALCOMMUNICATIONS GMBH | ||
| 4 | 04260648620015 | 2.5 | Ashvins variant HEYEX 2 / HEYEX PACS | MEDICALCOMMUNICATIONS GMBH | ||
| 5 | 04260648620008 | Ashvins 2020 | Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management | MEDICALCOMMUNICATIONS GMBH | ||
| 6 | 04260632470039 | 5.3 | Version 5.3 includes all minor versions and patch levels of 5.3 | JiveX | VISUS HEALTH IT GMBH | |
| 7 | 04260632470022 | 5.2 | Version 5.2 includes all minor versions and patch levels of 5.2 | JiveX | VISUS HEALTH IT GMBH | |
| 8 | 04260632470015 | 5.1 | Version 5.1 includes all minor versions and patch levels of 5.1 | JiveX | VISUS HEALTH IT GMBH | |
| 9 | 04260521365019 | 3.0 Galway | exoplan is a medical software, intended to support the pre-operative planning of exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides. | exoplan | EXOCAD GMBH | |
| 10 | 04260521365002 | 2.3 Matera | exoplan is a medical software, intended to support the pre-operative planning of exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal.exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions.The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides. | exoplan | EXOCAD GMBH | |
| 11 | 04260495880389 | 3.8.0 | 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 | |
| 12 | 04260495880372 | 3.7.0 | 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 | |
| 13 | 04260495880365 | 3.6.0 | 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 | |
| 14 | 04260495880358 | 3.5.0 | 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 | |
| 15 | 04260495880341 | 3.4.0 | 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 | |
| 16 | 04260483290183 | 2.4 | 2.4.0.229939, Release date: 2021-09-032.4.1.252491, Release date: 2022-03-25 | DynaCAD Lung | MEVIS MEDICAL SOLUTIONS AG | |
| 17 | 04260483290176 | 1.7 | 1.7.0.228241, Release date: 2021-03-181.7.1.252491, Release date: 2022-03-25 | Veolity | MEVIS MEDICAL SOLUTIONS AG | |
| 18 | 04260483290169 | 3.2 | DynaSuite Neuro | MEVIS MEDICAL SOLUTIONS AG | ||
| 19 | 04260483290114 | 2.3 | DynaCAD Lung | MEVIS MEDICAL SOLUTIONS AG | ||
| 20 | 04260483290091 | 1.4 | Veolity | MEVIS MEDICAL SOLUTIONS AG | ||
| 21 | 04260483290077 | 3.1 | DynaSuite Neuro | MEVIS MEDICAL SOLUTIONS AG | ||
| 22 | 04260483290053 | 2.2 | DynaCAD Lung | MEVIS MEDICAL SOLUTIONS AG | ||
| 23 | 04260483290039 | 1.3 | Veolity | MEVIS MEDICAL SOLUTIONS AG | ||
| 24 | 04260476810015 | 3 | Software for biopsy needle guide planning and tracking. | BioJet Target | MEDICAL TARGETING TECHNOLOGIES GMBH | |
| 25 | 04260476510038 | v1 (US) | aycan mobile | AYCAN DIGITALSYSTEME GMBH | ||
| 26 | 04260476510021 | v3 | aycan workstation | AYCAN DIGITALSYSTEME GMBH | ||
| 27 | 04260456230147 | 4.80.0 | CHILI PACS is a picture archiving and communication system with image processing CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning. | CHILI PACS | CHILI GMBH | |
| 28 | 04260456230130 | 4.78.0 | CHILI PACS | CHILI GMBH | ||
| 29 | 04260456230123 | 4.76.0 | CHILI PACS | CHILI PACS | CHILI GMBH | |
| 30 | 04260456230116 | 4.74.0 | CHILI PACS | CHILI GMBH | ||
| 31 | 04260456230109 | 4.72.0 | CHILI PACS | CHILI GMBH | ||
| 32 | 04260456230093 | 4.70.0 | CHILI PACS | CHILI PACS | CHILI GMBH | |
| 33 | 04260456230086 | 4.68.0 | CHILI PACS 4.68.0 | CHILI PACS | CHILI GMBH | |
| 34 | 04260456230079 | 4.66.0 | CHILI PACS 4.66.0 | CHILI PACS | CHILI GMBH | |
| 35 | 04260456230062 | 4.64.0 | CHILI PACS 4.64.0 | CHILI PACS | CHILI GMBH | |
| 36 | 04260456230055 | 4.62.0 | CHILI PACS 4.62.0 | CHILI PACS | CHILI GMBH | |
| 37 | 04260456230048 | 4.60 | CHILI GmbH | CHILI GMBH | ||
| 38 | 04260456230031 | 4.58 | CHILI PACS 4.58 | CHILI PACS | CHILI GMBH | |
| 39 | 04260456230024 | 4.56 | CHILI PACS 4.56 | CHILI PACS | CHILI GMBH | |
| 40 | 04260456230017 | 4.54 | CHILI PACS 4.54 | CHILI PACS | CHILI GMBH | |
| 41 | 04260456230000 | 4.52 | CHILI PACS 4.52 | CHILI PACS | CHILI GMBH | |
| 42 | G090AIM11 | 1 | AIM1 | AI Metrics is a thin client software application used with general purpose compu AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: • Manual annotation tools for users to select regions of interest (ROIs), • Semi-automatic lesion segmentation suggestions for user-selected ROIs, • Automatic measurement and display of long and short axis of segmented lesions, • Automatic tabulation and summation of measurements,• Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), • Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and • Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report. | AI Metrics | AI METRICS, LLC |
| 43 | G01900 | 06 | ThinkingNet | THINKING SYSTEMS CORPORATION | ||
| 44 | G003DM01 | 1 | 3D printed patient specific replicas of patient anatomy | 3D Anatomic Model | RICOH USA, INC. | |
| 45 | EOLEOLEASPHEREV3P01 | 3.0 | Olea Sphere V3.0 is an image processing software package to be used by trained p Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 46 | EOLEOLEASPHEREV2P31 | 2.3 | Olea Sphere V2.3 is an image processing software package to be used by trained p Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 47 | EOLEFMRIV1P00 | V1.0 | Functional MR V1.0 is an optional image processing software application that is Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers.Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis.Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. | FUNCTIONAL MR | OLEA MEDICAL USA | |
| 48 | EOLEBREASTSCAPEV1P00 | V1.0 | breastscape V1.0 is an optional image processing software application that is in breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.breastscape V1.0 includes 2 software modules :- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.- BreastLoc to assist users in planning MR guided breast interventional procedures.Data and images are acquired through DICOM compliant imaging devices and modalities. | BREASTSCAPE | OLEA MEDICAL USA | |
| 49 | 04260361440204 | TTA2.51 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 50 | 04260361440198 | TTA2.42 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH |