| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04056869003382 | 10036500 | ITX | Transducer, ultrasonic, diagnostic | 2 | P10 Transducer | ||
| 2 | 04056869002392 | 10183311 | LLZ | System, image processing, radiological | 2 | Scenium SPECT_V | ||
| 3 | 04056869002101 | 08716511 | LLZ | System, image processing, radiological | 2 | SW-Key: NMG_SCENIUM | ||
| 4 | 04056869001173 | 10275007 | KPS | System, tomography, computed, emission | 2 | Symbia_T | ||
| 5 | 04056869267081 | 11503525 | ITX | Transducer, ultrasonic, diagnostic | 2 | CW8 Transducer | ||
| 6 | 04056869062020 | 10787117 | ITX | Transducer, ultrasonic, diagnostic | 2 | 9EC4 Transducer | ||
| 7 | 04056869274959 | 11289565 | ITX | Transducer, ultrasonic, diagnostic | 2 | 7VC2 Transducer | ||
| 8 | 04056869002866 | 08266709 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | ||
| 9 | 04056869053882 | 11286583 | 59645 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | |
| 10 | 04056869053875 | 11286582 | 8248186 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | |
| 11 | 04056869173566 | 11148775 | 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 | ACUSON Sequoia Diagnostic Ultrasound System | ||
| 12 | 04056869109466 | 11336164 | ITX | Transducer, ultrasonic, diagnostic | 2 | BP10-3 Transducer | ||
| 13 | 04056869264769 | 11364753 | KPS | System, tomography, computed, emission | 2 | Symbia Pro.specta X7 | ||
| 14 | 04056869238265 | 11361589 | ITX | Transducer, ultrasonic, diagnostic | 2 | 13L4 Transducer | ||
| 15 | 04056869053813 | 11286576 | 59644 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
| 16 | 04056869053806 | 11286575 | 58525 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
| 17 | 04056869052076 | 11014579 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | ||
| 18 | 04056869051925 | 11319697 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | ||
| 19 | 04056869030005 | 11284381 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Acuson NX2 Diagnostic Ultrasound System | ||
| 20 | 04056869027258 | 11014031 | ITX | Transducer, ultrasonic, diagnostic | 2 | VFX9-4 Transducer | ||
| 21 | 04056869027227 | 10787446 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | P10 Handheld Ultrasound system | ||
| 22 | 04056869006833 | 11149925 | LLZ | System, image processing, radiological | 2 | sUSBA Software | ||
| 23 | 04056869006512 | 10852687 | 9600153000 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA023E Transducer | |
| 24 | 04056869006505 | 10852686 | 9600165000 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA230E Transducer | |
| 25 | 04056869005577 | 10784498 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | ||
| 26 | 04056869005560 | 10784497 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | ||
| 27 | 04056869005379 | 10033454 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | ||
| 28 | 04056869005287 | 08267986 | 8266709 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | |
| 29 | 04056869005201 | 08259645 | 59645 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | |
| 30 | 04056869005195 | 08259644 | 59644 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
| 31 | 04056869005188 | 08259643 | 59643 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
| 32 | 04056869005102 | 08247447 | 47447 | ITX | Transducer, ultrasonic, diagnostic | 2 | 8L5 Transducer | |
| 33 | 04056869005003 | 05918102 | 59180 | ITX | Transducer, ultrasonic, diagnostic | 2 | CX5-2 TRANSDUCER-E | |
| 34 | 04056869004549 | 10349999 | ITX | Transducer, ultrasonic, diagnostic | 2 | MC9-4 Transducer | ||
| 35 | 04056869004419 | 05726625 | ITX | Transducer, ultrasonic, diagnostic | 2 | 3.5C40S Transducer | ||
| 36 | 04056869004303 | 11235411 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Acuson NX3 Elite Diagnostic Ultrasound System | ||
| 37 | 04056869004297 | 11235612 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Acuson NX3 Diagnostic Ultrasound System | ||
| 38 | 04056869004266 | 10855958 | OBJ | Catheter, ultrasound, intravascular | 2 | AcuNav Volume Ultrasound Catheter | ||
| 39 | 04056869004259 | 10852646 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | ACUSON P300 Diagnostic Ultrasound System | ||
| 40 | 04056869003825 | 11013911 | ITX | Transducer, ultrasonic, diagnostic | 2 | EV-8C4 Transducer | ||
| 41 | 04056869003818 | 11013910 | ITX | Transducer, ultrasonic, diagnostic | 2 | EV-8C4 Transducer | ||
| 42 | 04056869003733 | 08267218 | 8267218 | ITX | Transducer, ultrasonic, diagnostic | 2 | 7L3 Transducer | |
| 43 | 04056869003627 | 05936237 | 5936237 | ITX | Transducer, ultrasonic, diagnostic | 2 | VFX9-4 Transducer | |
| 44 | 04056869003528 | 10853679 | LLZ | System, image processing, radiological | 2 | syngo Ultrasound Workplace | ||
| 45 | 04056869003504 | 10433921 | LLZ | System, image processing, radiological | 2 | syngo SC2000 Workplace | ||
| 46 | 04056869003443 | 11147262 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA230E Transducer | ||
| 47 | 04056869003429 | 11147260 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA023E Transducer | ||
| 48 | 04056869003399 | 07472272 | 7472272 | ITX | Transducer, ultrasonic, diagnostic | 2 | P10-4 Transducer | |
| 49 | 04056869003252 | 07465672 | 7465672 | ITX | Transducer, ultrasonic, diagnostic | 2 | CH6-2 Transducer | |
| 50 | 04056869003153 | 08241116 | 8241116 | ITX | Transducer, ultrasonic, diagnostic | 2 | 8L5 Transducer |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | Rapid | ISCHEMAVIEW, INC. |
| 2 | B7671R521 | 5.2.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 3 | B7671R520 | 5.2.0 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 4 | B7671R512 | 5.1.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 5 | B7671R511 | 5.1.1 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 6 | B7671R5030 | 5.0.3 | Rapid | ISCHEMAVIEW, INC. | ||
| 7 | B761RAPID510 | 5.1 | Rapid 5.1 | Rapid | ISCHEMAVIEW, INC. | |
| 8 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 9 | B761RAPID5020 | 5.0.2 | RAPID | ISCHEMAVIEW, INC. | ||
| 10 | B761RAPID5010 | 5.0.1 | RAPID | ISCHEMAVIEW, INC. | ||
| 11 | B761RAPID500 | 5.0 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 12 | B761RAPID49101 | 4.9.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 13 | B761RAPID48302 | 4.8.3 | RAPID | RAPID is a Platform for brain image analysis. | RAPID | ISCHEMAVIEW, INC. |
| 14 | B745VASCUCAPA2 | A.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 15 | B745ELUCIDVIVOA3 | A.3 | ElucidVivo | ELUCID BIOIMAGING INC. | ||
| 16 | B745A40 | A.1.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 17 | 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 |
| 18 | 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 | |
| 19 | B664CVM20 | CVM2 | Arterys Cardio DL | ARTERYS INC. | ||
| 20 | B664AVM30 | AVM3 | Arterys Viewer | ARTERYS INC. | ||
| 21 | B664AOM40 | AOM4 | Arterys Oncology DL | ARTERYS INC. | ||
| 22 | B664AMM60 | AMM6 | Arterys MICA | ARTERYS INC. | ||
| 23 | B664AMM50 | AMM5 | Arterys MICA | ARTERYS INC. | ||
| 24 | B621ICOBRAINCTP10 | 1 | icobrain ctp | ICOMETRIX NV | ||
| 25 | B621ICOBRAIN60 | 6 | icobrain | ICOMETRIX NV | ||
| 26 | B621ICOBRAIN50 | 5 | icobrain | ICOMETRIX NV | ||
| 27 | B621ICOBRAIN40 | 4.0 | icobrain | ICOMETRIX NV | ||
| 28 | 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 | |
| 29 | 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 | |
| 30 | B581LIFESYSPACSV20 | 2 | LIFESYS PACS v2 | LIFESYS PACS | LIFETRACK MEDICAL SYSTEMS INC. | |
| 31 | B557ECHOINSIGHT0 | 3.2.0 | Software for analysis of echocardiogram | EchoInsight | EPSILON IMAGING | |
| 32 | 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 | |
| 33 | 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 |
| 34 | B433AN0 | 7 | AccessNET | ASPYRA, LLC | ||
| 35 | 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. |
| 36 | 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 | |
| 37 | B403IQS160 | 1.6 | 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 | |
| 38 | B403IQS150 | 1.5 | 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 adoped for storing, processing, routing and reporting. | iQ-SYSTEM PACS | IMAGE INFORMATION SYSTEMS EUROPE GMBH | |
| 39 | B403IQS140 | 1.4 | 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 adopted for storing, processing, routing and reporting. | iQ-SYSTEM PACS | IMAGE INFORMATION SYSTEMS EUROPE GMBH | |
| 40 | B403IQS130 | 1.3 | iQ-SYSTEM PACS is a software device for network or web-based medical image viewi iQ-SYSTEM PACS is a software device 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 | |
| 41 | B403IQS120 | 1.2 | iQ-SYSTEM PACS is a software device for network or web-based medical image viewi iQ-SYSTEM PACS is a software device 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 | |
| 42 | B383REV090203000 | 9.2.3 | Diagnostic web DICOM viewer | RemotEye Viewer | NEOLOGICA SRL | |
| 43 | B383REV090202000 | 9.2.2 | Diagnostic web DICOM viewer | RemotEye Viewer | NEOLOGICA SRL | |
| 44 | B383REV090201000 | 9.2.1 | Diagnostic web DICOM viewer | RemotEye Viewer | NEOLOGICA SRL | |
| 45 | B383REV090200000 | 9.2.0 | Diagnostic web DICOM viewer | RemotEye Viewer | NEOLOGICA SRL | |
| 46 | B383REV090102000 | 9.1.2 | Diagnostic web DICOM viewer | RemotEye Viewer | NEOLOGICA SRL | |
| 47 | B377GMR1602008X0 | 2.1.x | CapSure Cloud is a secure cloud-based web application for medical image archivin CapSure Cloud is a secure cloud-based web application for medical image archiving and management. | CapSure Cloud | GLOBALMEDIA GROUP, LLC | |
| 48 | B377GMD306100XXX0 | 2.3.x.x | eNcounterCloud is a secure cloud-based web application for medical image archivi eNcounterCloud is a secure cloud-based web application for medical image archiving and management. | eNcounterCloud | GLOBALMEDIA GROUP, LLC | |
| 49 | B373VPS1090 | 1.0.9 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with toolsto aid them in reading, interpreting, reporting, and treatment planning. Visible Patient Suite accepts DICOMcompliant medical images acquired from a variety of imaging devices, including CT, MR.This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.The software provides several categories of tools. It includes basic imaging tools for general images, including 2Dviewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion,surface rendering, measurements, reporting, storing, general image management and administration tools, etc.It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visiblein the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basicimage filters, etc.It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definitionthrough vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling.The software is designed to be used by trained professionals (including physicians, surgeons and technicians) andis intended to assist the clinician who is solely responsible for making all final patient management decisions. | Visible Patient Suite | VISIBLE PATIENT | |
| 50 | B373VPS10170 | 1.0.17 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi- Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc.It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc.It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition throughvascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling.The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. | Visible Patient Suite | VISIBLE PATIENT |