| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00670082000191 | 1.4 | SYN-0027 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Guide Software | |
| 2 | 00670082000122 | 1.1 | SYN-0627 | LLZ | System, Image Processing, Radiological | 2 | ImageDrive Pro | |
| 3 | 00670082000108 | SYN-0596 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Pointer Sterilizable Storage Tray | ||
| 4 | 00670082000078 | 1.3 | SYN-0027 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Guide Software | |
| 5 | 00670082000054 | SYN-0022 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Guide Sterilizable Storage Tray | ||
| 6 | 00670082000207 | SYN-0652 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Trackable Suction - Tube 10-L-30 | |||
| 7 | 00670082000375 | 1.5 | SYN-0027 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Guide Software | |
| 8 | 00670082000245 | SYN-0656 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 12-L-90 | ||
| 9 | 00670082000160 | 1.4 | SYN-0004 | LLZ | System, Image Processing, Radiological | 2 | BrightMatter Plan | |
| 10 | 00670082000153 | SYN-0651 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 6-L-30 | ||
| 11 | 00670082000030 | SYN-0015 | HAW | Neurological Stereotaxic Instrument | Tracking Array for Brainpath | |||
| 12 | 00670082000306 | SYN-0674 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 10-S-30 | ||
| 13 | 00670082000412 | 1.6 | SYN-0866 | LLZ | System, Image Processing, Radiological | 2 | BrightMatter Plan | |
| 14 | 00670082000382 | SYN-0783 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Suction Set Malleable | ||
| 15 | 00670082000368 | 1.5 | SYN-0004 | LLZ | System, Image Processing, Radiological | 2 | BrightMatter Plan | |
| 16 | 00670082000283 | SYN-0672 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 6-S-30 | ||
| 17 | 00670082000146 | SYN-0618 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Sterilizable Storage Tray | ||
| 18 | 00670082000139 | 13.1 | SYN-0524 | LLZ | System, Image Processing, Radiological | 2 | ClearCanvas Personal Edition Workstation | |
| 19 | 00670082000238 | SYN-0655 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 10-L-90 | ||
| 20 | 00670082000313 | SYN-0675 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 4-M-30 | ||
| 21 | 00670082000177 | SYN-0647 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Suction Handle | ||
| 22 | 00670082000061 | SYN-0026 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Guide | ||
| 23 | 00670082000474 | SYN-0903 | Robotic Digital Microscope | EPT | Microscope, Surgical | 1 | Modus V | |
| 24 | 00670082000467 | SYN-0902 | Robotic Digital Microscope | EPT | Microscope, Surgical | 1 | Modus V | |
| 25 | 00670082000443 | 2.0 | SYN-0866 | LLZ | System, Image Processing, Radiological | 2 | Modus Plan | |
| 26 | 00670082000115 | 1.1 | SYN-0578 | LLZ | System, Image Processing, Radiological | 2 | ImageDrive Clinical | |
| 27 | 00670082000092 | SYN-0642 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Pointer | ||
| 28 | 00670082000047 | SYN-0021 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Patient Reference | ||
| 29 | 00670082000023 | SYN-0014 | HAW | Neurological Stereotaxic Instrument | 2 | BrightMatter Guide Calibration Block | ||
| 30 | 00670082000221 | SYN-0654 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 6-L-90 | ||
| 31 | 00670082000450 | SYN-0777 | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Evry | ||
| 32 | 00670082000337 | SYN-0677 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 8-M-30 | ||
| 33 | 00670082000320 | SYN-0676 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 6-M-30 | ||
| 34 | 00670082000290 | SYN-0673 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 8-S-30 | ||
| 35 | 00670082000276 | SYN-0671 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 4-S-30 | ||
| 36 | 00670082000184 | SYN-0657 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Synaptive Trackable Suction - Standard Suction Set | ||
| 37 | 00670082000214 | SYN-0653 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 12-L-30 | ||
| 38 | 00670082000344 | SYN-0678 | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | Trackable Suction - Tube 10-M-30 | ||
| 39 | 00670082000016 | SYN-0013 | HAW | Neurological Stereotaxic Instrument | 2 | Pointer Tool (SS) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04571320222008 | Ziostation2 | Ziostation2 is a basic DICOM image management system to further aid clinicians i Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging toolsand techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound,Digital X-ray X-ray Angiography, PET, SPECT, NM, SC, Mammography, X-ray Radiofluoroscopic image, RTImage. | Ziostation2 | ZIOSOFT, INC. | |
| 2 | 04562122958639 | DAS-RS1 | ULTRASOUND DATA ANALYSIS SYSTEM | HITACHI | HITACHI, LTD. | |
| 3 | 04560141950382 | V1.94R00E | ImagePilot | KONICA MINOLTA, INC. | ||
| 4 | 04560141949584 | V1.93R00E | ImagePilot | KONICA MINOLTA, INC. | ||
| 5 | 04560141949492 | V1.92R00E | ImagePilot | KONICA MINOLTA, INC. | ||
| 6 | 04560141947788 | ACDY | KONICAMINOLTA DI-X1 | KONICA MINOLTA, INC. | ||
| 7 | 04560141947771 | ACDX | KONICAMINOLTA DI-X1 | KONICA MINOLTA, INC. | ||
| 8 | 04560141945166 | A4C1 | CS-7 | KONICA MINOLTA, INC. | ||
| 9 | 04560141944961 | D9MA | ImagePilot | KONICA MINOLTA, INC. | ||
| 10 | 04548213030804 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 11 | 04548213026982 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 12 | 04548213026975 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 13 | 04548213026968 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 14 | 04548213026951 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 15 | 04548213026944 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 16 | 04548213026852 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 17 | 04548213026845 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 18 | 04548213026838 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 19 | 04548213026821 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 20 | 04548213026814 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 21 | 04548213026807 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 22 | 04548213026791 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 23 | 04548213026784 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 24 | 04548213026777 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 25 | 04548213026760 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 26 | 04548213025299 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 27 | 04548213025282 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 28 | 04548213025183 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 29 | 04548213025176 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 30 | 04548213024735 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 31 | 04548213024728 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 32 | 04548213024711 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 33 | 04548213024704 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 34 | 04548213024698 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 35 | 04547410345438 | MIS-1000 | ASPIRE Bellus II is medical imaging software that is intended to provide trained ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc. | ASPIRE Bellus II | FUJIFILM CORPORATION | |
| 36 | 04547410333527 | DR-ID800CL | The Console is a workstation intended to associate digital (for DR) images with The Console is a workstation intended to associate digital (for DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | DR-ID800CL | FUJIFILM CORPORATION | |
| 37 | 04547410324877 | Synapse 3D | The product “Synapse 3D Base Tools” is a system that receives and retrieves DICO The product “Synapse 3D Base Tools” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis. | Synapse 3D | FUJIFILM CORPORATION | |
| 38 | 04547410316926 | CR-VW674 | FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patie FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR Viewcan receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images. | FCRView | FUJIFILM CORPORATION | |
| 39 | 04547410316872 | DR-ID900CL | The DR-ID 900CL is a workstation intended to associate digital (for CR and/or DR The DR-ID 900CL is a workstation intended to associate digital (for CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | DR-ID900CL | FUJIFILM CORPORATION | |
| 40 | 04547410316865 | DR-ID300CL | The Console Advance is a workstation intended to associate digital (for CR and/o The Console Advance is a workstation intended to associate digital (for CR and/or DR) images. with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | FDXConsole | FUJIFILM CORPORATION | |
| 41 | 04540217011469 | 502-24400-12 | DAR-8000i | SHIMADZU CORPORATION | ||
| 42 | 04540217011452 | 502-24400-11 | DAR-8000i | SHIMADZU CORPORATION | ||
| 43 | 04260648620022 | 2021 (Build 1920) | Ashvins | MEDICALCOMMUNICATIONS GMBH | ||
| 44 | 04260648620015 | 2.5 | Ashvins variant HEYEX 2 / HEYEX PACS | MEDICALCOMMUNICATIONS GMBH | ||
| 45 | 04260648620008 | Ashvins 2020 | Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management | MEDICALCOMMUNICATIONS GMBH | ||
| 46 | 04260632470039 | 5.3 | Version 5.3 includes all minor versions and patch levels of 5.3 | JiveX | VISUS HEALTH IT GMBH | |
| 47 | 04260632470022 | 5.2 | Version 5.2 includes all minor versions and patch levels of 5.2 | JiveX | VISUS HEALTH IT GMBH | |
| 48 | 04260632470015 | 5.1 | Version 5.1 includes all minor versions and patch levels of 5.1 | JiveX | VISUS HEALTH IT GMBH | |
| 49 | 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 | |
| 50 | 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 |