Other products from "EXINI DIAGNOSTICS AB"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07350002336021 02 602 PYLARIFY AI is intended to be used by healthcare professionals and researchers f PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis. LLZ System, Image Processing, Radiological 2 PYLARIFY AI
2 07350002336014 01 601 PYLARIFY AI is a software only medical device that provides quantitative assessm PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. LLZ System, Image Processing, Radiological 2 PYLARIFY AI
3 07350002335017 01 501 aPROMISE is a softwareonly medical device that provides quantitative assessments aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. LLZ System, Image Processing, Radiological 2 aPROMISE
4 07350002332030 03 203 The aBSI is a software-only medical device that provides a fully quantitative as The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results. LLZ System, Image Processing, Radiological 2 aBSI
Other products with the same Product Code "LLZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00860461001707 Version 2.2 FG0064 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers uLab Systems uDesign ULAB SYSTEMS, INC.
2 00860290000384 v.6 XoranConnect XORAN TECHNOLOGIES LLC
3 00860290000322 5.2 XoranConnect XORAN TECHNOLOGIES LLC
4 00860148000894 4.2 A mobile medical imaging software package that is used for the viewing, registra A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of medical images. It can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. Mobile MIM MIM SOFTWARE INC.
5 00860148000870 4.0 A medical image software package that aids the physician in the diagnosis of pat A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians. MIMviewer MIM SOFTWARE INC.
6 00860148000863 7.0 A medical imaging software package that provide imaging solutions in the fields A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging. MIM MIM SOFTWARE INC.
7 00860148000832 4.1 A mobile medical imaging software package that is used for the viewing, registra A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of medical images. It can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. Mobile MIM MIM SOFTWARE INC.
8 00860148000825 3.9 A medical image software package that aids the physician in the diagnosis of pat A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians. MIMviewer MIM SOFTWARE INC.
9 00860148000818 6.9 A medical imaging software package that provide imaging solutions in the fields A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging. MIM MIM SOFTWARE INC.
10 00860059002109 v1 mfiVerse MULTIFUNCTIONAL IMAGING, LLC
11 00860008704184 MNMS Patient-specific, partial-face 3D printed anatomic model depicting a patient’s t Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only MirrorMe3D Nose Model - Simulation MIRRORME3D, LLC
12 00860008704177 MNMB Patient-specific, partial face 3D printed anatomic model depicting a patient’s b Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only. MirrorMe3D Nose Model - Baseline MIRRORME3D, LLC
13 00860008704160 MRCS Patient-specific, partial-face 3D printed anatomic model depicting a patient’s t Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only. Treatment Plan Rhinoplasty Model MIRRORME3D, LLC
14 00860008704153 MRCB Patient-specific, partial face 3D printed anatomic model depicting a patient’s b Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only. Baseline Rhinoplasty Model MIRRORME3D, LLC
15 00860008704146 FFS Patient-specific, full-face 3D printed anatomic model depicting a patient’s trea Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only. Full Face Sim Model MIRRORME3D, LLC
16 00860008704139 FFB Patient-specific, full-face 3D printed anatomic model depicting a patient’s base Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only. Full Face Baseline Model MIRRORME3D, LLC
17 00860007104909 1 TRAQinform IQ is a software tool used to aid in evaluation and information manag TRAQinform IQ is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, oncologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.TRAQinform IQ assists in the following indications:• Receive, store, retrieve, display and process digital medical images.• Create, display and print reports from those images.• Provide medical professionals with the ability to display, register, and fuse medical images.• Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.• Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs TRAQinform IQ AIQ GLOBAL, INC.
18 00860003884119 BrainStorm SuRgical Planner (SRP) BrainStorm Desktop System SRP BrainStorm SURGICAL THEATER LLC
19 00860003884102 SyncAR SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System SyncAR SNAP SURGICAL THEATER LLC
20 00860003424834 1015-915-505 OrthoGrid Hip AI for non-invasive software system that provides image analysis t OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement OrthoGrid Hip AI ORTHOGRID SYSTEMS, INC.
21 00860003424827 2010-915-502 OrthoGrid Trauma for non-invasive software system that provides image analysis t OrthoGrid Trauma for non-invasive software system that provides image analysis tools for trauma procedures OrthoGrid Hip Trauma ORTHOGRID SYSTEMS, INC.
22 00860003424810 4015-915-501 OrthoGrid Hip Preservation 3.0 non-invasive software system that provides image OrthoGrid Hip Preservation 3.0 non-invasive software system that provides image analysis tools for Hip Preservation. OrthoGrid Hip Preservation ORTHOGRID SYSTEMS, INC.
23 00860003424803 1015-915-504 OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement OrthoGrid Hip ORTHOGRID SYSTEMS, INC.
24 00860002545707 2.x The Koios DS Breast system is designed to assist qualified interpreting physicia The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report. Koios Medical KOIOS MEDICAL, INC.
25 00860002380087 7 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. uLab Systems uDesign ULAB SYSTEMS, INC.
26 00860002380070 6.0 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. uLab Systems uDesign ULAB SYSTEMS, INC.
27 00860002380049 5.9 FG0064 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. uLab Systems uDesign ULAB SYSTEMS, INC.
28 00860002380032 Version 5.8 FG0064 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. uLab Systems uDesign ULAB SYSTEMS, INC.
29 00860002380025 Version 5.6 FG0064 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. uLab Systems uDesign ULAB SYSTEMS, INC.
30 00860002380018 Version 5.5 FG0064 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers uLab Systems uDesign ULAB SYSTEMS, INC.
31 00860002380001 Version 5 FG0064 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers uLab Systems uDesign ULAB SYSTEMS, INC.
32 00860002319803 4.0.10.27 DICOM Router UltraGATEWAY ULTRARAD CORPORATION
33 00860001924114 v2.0 Cleerly Labs is used by trained medical professionals as an interactive tool for Cleerly Labs is used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries. Cleerly Labs CLEERLY, INC.
34 00860001148596 2.0.2.8 UltraRAD Product User Web Interface UltraMANAGEMENT UTILITY ULTRARAD CORPORATION
35 00860001148589 1.0.0.12 UltraRAD Product User Web Interface UltraMANAGEMENT UTILITY ULTRARAD CORPORATION
36 00860001148572 3.0.2.362 DICOM Modality Worklist UltraBROKER ULTRARAD CORPORATION
37 00860001148565 6.0.0.0 DICOM Viewer UltraWEB ULTRARAD CORPORATION
38 00860001148558 3.0.3.2 UltraPREFETCH automatically retrieves studies and sends to any DICOM client, on UltraPREFETCH automatically retrieves studies and sends to any DICOM client, on a rule based criteria. UltraPREFETCH ULTRARAD CORPORATION
39 00860001148541 1.0.0.0 DICOM file import tool UltraMEDIA ULTRARAD CORPORATION
40 00860001148534 3.0.4.9 DICOM Storage UltraARCHIVE ULTRARAD CORPORATION
41 00860001148527 3.0.4.9 DICOM Router UltraGATEWAY ULTRARAD CORPORATION
42 00860001148510 1.0.0.2 Allows sites a methodology to securely deliver electronic results and images to Allows sites a methodology to securely deliver electronic results and images to their referring physicians UltraDISTRIBUTOR ULTRARAD CORPORATION
43 00860001148503 2.0.0.0 Clinical image viewer UltraVISION ULTRARAD CORPORATION
44 00860000606189 Version 1.0 BrainInsight HYPERFINE RESEARCH, INC.
45 00860000358705 1.0 ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact w ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support. ProKnow DS PROKNOW, LLC
46 00860000233118 A VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or wit VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis. VirtuOst VFA O N DIAGNOSTICS LLC
47 00860000171212 2.x SubtleMR is an image processing software that can be used for image enhancement SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI. SubtleMR SUBTLE MEDICAL, INC.
48 00860000171205 2.x SubtlePET is an image processing software intended for use by radiologists and n SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI). SubtlePET SUBTLE MEDICAL, INC.
49 00860000004817 1.1 RSI-MRI+ is standalone software that is used by radiologists, urologists, and ot RSI-MRI+ is standalone software that is used by radiologists, urologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ acceptsDICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optionalautomated fusion of derived image data with anatomical T2-weighted MR images. Some of the features of RSI-MRI+ include: • Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps. • Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series. • Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (AI) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Segmentation Series. • Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image. • Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software. NOTE: The RSI-MRI+ supported protocols differ from PI-RADS v2.1 in that they have lower inplane resolution for T2W images and thicker slices for the GE DW RSI-MRI+ CORTECHS LABS INC
50 00860000004800 1.5 CT CoPilot is intended for use in automating post-acquisition quantitative analy CT CoPilot is intended for use in automating post-acquisition quantitative analysis of CT images of the brain for patients aged 18 or older. CT CoPilot performs automatic reformatting, labeling and quantification of segmentable structures from a set of CT images of the brain. Output of the software provides these values as numerical volumes and images which have been annotated with graphical color overlays, with each color representing a specific brain structure. When CT imaging is performed more than once on a patient, the current data is co-registered to the most recently processed prior exam of the same patient, facilitating comparison between the studies using CT CoPilot. Voxel-by-voxel subtraction maps of the pixel density change in Hounsfield Units (HU) are generated in up to 3 dimensions between the current and most recent processed prior exam of the patient. CT CoPilot CORTECHS LABS INC