| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00350227300071 | 1.09 | FUSE version 1.09 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 2 | 00350227300064 | 1.08 | FUSE version 1.08 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 3 | 00350227300057 | 1.07 | FUSE version 1.07 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 4 | 00350227300040 | 1.06 | FUSE version 1.06 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 5 | 00350227300033 | 1.05 | FUSE version 1.05 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 6 | 00350227300026 | 1.02 | FUSE version 1.02 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 7 | 00350227300019 | 1.01 | FUSE version 1.01 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 8 | 00350227300002 | 1.00 | Fuse version 1.00 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 9 | 00350227000223 | 1.04 | FUSE version 1.04 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 10 | 00350227000216 | 1.03 | FUSE version 1.03 | LLZ | System, Image Processing, Radiological | 2 | FUSE | |
| 11 | 00350227000339 | 21.20 | DICOM MEDIA EAGLESOFT VERSION 21.20 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 12 | 00350227000360 | 21.20 | VOICE EAGLESOFT v21.20 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 13 | 00350227000353 | 21.20 | LORIN LIBRARY EAGLESOFT v21.20 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 14 | 00350227000346 | 21.20 | DICOM NETWORK CD EAGLESOFT v21.20 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 15 | 00350227000322 | 21.20 | DIGITAL INTEGRATION CD VERSION 21.20 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 16 | 00350227000315 | 21.20 | ES DUAL DATABASE (US) VERSION 21.20 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 17 | 00350227000308 | 21.20 | EAGLESOFT INSTALL v21.20 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 18 | 00350227000292 | 21.10 | VOICE EAGLESOFT v21.10 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 19 | 00350227000285 | 21.10 | LORIN LIBRARY EAGLESOFT v21.10 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 20 | 00350227000278 | 21.10 | DICOM NETWORK CD EAGLESOFT v21.10 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 21 | 00350227000254 | 21.10 | DIGITAL INTEGRATION CD | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 22 | 00350227000247 | 21.10 | ES DUAL DATABASE (US) VERSION 21.10 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 23 | 00350227000230 | 21.10 | EAGLESOFT VERSION 21.10 INSTALL | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 24 | 00350227000209 | 21.00 | VOICE EAGLESOFT v21.00 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 25 | 00350227000193 | 21.00 | LORIN LIBRARY EAGLESOFT v21.00 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 26 | 00350227000186 | 21.00 | DICOM NETWORK CD EAGLESOFT v21.00 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 27 | 00350227000179 | 21.00 | DICOM MEDIA EAGLESOFT VERSION 21.00 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 28 | 00350227000162 | 21.00 | DIGITAL INTEGRATION CD | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 29 | 00350227000131 | 20.10 | EAGLESOFT VERSION 20.10 INSTALL | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 30 | 00350227000124 | 20.00 | EAGLESOFT VERSION 20.00 INSTALL | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 31 | 00350227000117 | 19.10 | DICOM NETWORK EAGLESOFT VERSION 19.10 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 32 | 00350227000100 | 19.10 | DICOM MEDIA EAGLESOFT VERSION 19.10 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 33 | 00350227000094 | 19.10 | EAGLESOFT VERSION 19.10 Install | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 34 | 00350227000087 | 18.10 | VOICE | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 35 | 00350227000070 | 18.10 | LORIN LIBRARY | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 36 | 00350227000063 | 18.10 | DICOM NETWORK CD | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 37 | 00350227000056 | 18.10 | DICOM MEDIA CD | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 38 | 00350227000049 | 18.10 | DIGITAL INTEGRATION CD | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 39 | 00350227000032 | 18.10 | ES DUAL DATABASE (US) | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 40 | 00350227000025 | 18.10 | EAGLESOFT VERSION 18.10 INSTALL | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT | |
| 41 | 00350227000018 | 19.00 | EAGLESOFT VERSION 19.00 | LLZ | System, Image Processing, Radiological | 2 | EAGLESOFT |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B940IVZBKIT0 | ImmersiveTouch4 | ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 2 | B940IMMERSIVEVIEW0 | V3.0 | The ImmersiveTouch simulators are intended as pre-operative software for simulat The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 3 | B843UNISYN6110 | 6-1-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 4 | B843UNISYN5610 | 5-6-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 5 | B843UNISYN5520 | 5-5-2-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 6 | B843UNISYN5510 | 5-5-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 7 | B843UNISYN5410 | 5-4-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 8 | B843UNISYN531P20 | 5-3-1-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 9 | B843UNISYN431P10 | 4-3-1-P1 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 10 | B843UNISYN425P20 | 4-2-5-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 11 | B80731 | Breast MRI SE | 3 | QuantX is a software program that is used to view and analyze patient breast images. | QuantX | QLARITY IMAGING, LLC |
| 12 | B80721 | Breast MRI Biopsy Guidance Plugin | 2 | The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assi The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures. | QuantX | QLARITY IMAGING, LLC |
| 13 | B801THINQ1130 | 1.1.3 | THINQ | CORTICOMETRICS LLC | ||
| 14 | B801THINQ1000 | 1.0.0 | THINQ | CORTICOMETRICS LLC | ||
| 15 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | Rapid | ISCHEMAVIEW, INC. |
| 16 | B7671R521 | 5.2.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 17 | B7671R520 | 5.2.0 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 18 | B7671R512 | 5.1.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 19 | B7671R511 | 5.1.1 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 20 | B7671R5030 | 5.0.3 | Rapid | ISCHEMAVIEW, INC. | ||
| 21 | B761RAPID510 | 5.1 | Rapid 5.1 | Rapid | ISCHEMAVIEW, INC. | |
| 22 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 23 | B761RAPID5020 | 5.0.2 | RAPID | ISCHEMAVIEW, INC. | ||
| 24 | B761RAPID5010 | 5.0.1 | RAPID | ISCHEMAVIEW, INC. | ||
| 25 | B761RAPID500 | 5.0 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 26 | B761RAPID49101 | 4.9.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 27 | B761RAPID48302 | 4.8.3 | RAPID | RAPID is a Platform for brain image analysis. | RAPID | ISCHEMAVIEW, INC. |
| 28 | B745VASCUCAPA2 | A.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 29 | B745ELUCIDVIVOA3 | A.3 | ElucidVivo | ELUCID BIOIMAGING INC. | ||
| 30 | B745A40 | A.1.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 31 | B725INITVV12 | 1.2 | INITVV | Visualize:Vascular is software that renders 3D images of vascular segments from Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging. | Visualize:Vascular | SALIENT IMAGING |
| 32 | B688IMAGEQUBE0 | ImageQube | ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication Sy ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports. | ImageQube | INTUITIVE IMAGING INFORMATICS, LLC | |
| 33 | B664CVM20 | CVM2 | Arterys Cardio DL | ARTERYS INC. | ||
| 34 | B664AVM30 | AVM3 | Arterys Viewer | ARTERYS INC. | ||
| 35 | B664AOM40 | AOM4 | Arterys Oncology DL | ARTERYS INC. | ||
| 36 | B664AMM60 | AMM6 | Arterys MICA | ARTERYS INC. | ||
| 37 | B664AMM50 | AMM5 | Arterys MICA | ARTERYS INC. | ||
| 38 | B621ICOBRAINCTP10 | 1 | icobrain ctp | ICOMETRIX NV | ||
| 39 | B621ICOBRAIN60 | 6 | icobrain | ICOMETRIX NV | ||
| 40 | B621ICOBRAIN50 | 5 | icobrain | ICOMETRIX NV | ||
| 41 | B621ICOBRAIN40 | 4.0 | icobrain | ICOMETRIX NV | ||
| 42 | B621ICOBRAIN30 | 3 | icobrain is software intended for automatic labeling, visualization and volumetr icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. | icobrain | ICOMETRIX NV | |
| 43 | B621ICOBRAIN20 | 2 | icobrain is software intended for automatic labeling, visualization and volumetr icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. | icobrain | ICOMETRIX NV | |
| 44 | B581LIFESYSPACSV20 | 2 | LIFESYS PACS v2 | LIFESYS PACS | LIFETRACK MEDICAL SYSTEMS INC. | |
| 45 | B557ECHOINSIGHT0 | 3.2.0 | Software for analysis of echocardiogram | EchoInsight | EPSILON IMAGING | |
| 46 | B554CSMD1000 | 1.0.0 | CoverScan is a medical image management and processing software package that all CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data.CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners. | CoverScan | PERSPECTUM LTD | |
| 47 | B501PLANET030101 | 3.1.1 | 3.1.1 | PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, ther PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities. | PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose | DOSISOFT |
| 48 | B433AN0 | 7 | AccessNET | ASPYRA, LLC | ||
| 49 | B409MISTAR320 | 3.2 | MISTAR32 | MIStar is a software package, which runs on a Windows-based PC platform. It allo MIStar is a software package, which runs on a Windows-based PC platform. It allows manipulation, visualization and processing of medical images acquired with various clinical scanners and stored in DICOM and /or other proprietary formats. MIStar allows transfer of DICOM 3.0 images over a medical imaging network.MIStar also provides post-processing of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also allows calculation of various perfusion related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability) from dynamic CT data. The results are displayed in a user-friendly graphic format as parametric images that provide supplementary information for diagnosis purposes. | MIStar | APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD. |
| 50 | B403IQS170 | 1.7 | iQ-SYSTEM PACS is a software for network or web-based medical image viewing and iQ-SYSTEM PACS is a software for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting. | iQ-SYSTEM PACS | IMAGE INFORMATION SYSTEMS EUROPE GMBH |