No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00858012005922 | V3.4 | D70141, D70142, D70160 | "PowerLook Density Assessment 3.4 is a software application intended for use wit "PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid. | LLZ | System, Image Processing, Radiological | 2 | PowerLook Density Assessment V3.4 |
2 | 00858012005854 | V7.2 | DSC017-04-US | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO with SLD, GE, US |
3 | 00858012005748 | 720823 | F5410-30 | Packaged Cutout 30mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 30mm, xFlex |
4 | 00858012005649 | 711110 | SK1050 | Surface Applicator Cone, 50mm | JAD | System, Therapeutic, X-Ray | 2 | Surface Applicator Cone, 50 mm |
5 | 00858012005601 | V7.2 | DSC017-01-US | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | PowerLook AMP PRO with SecondLook Digital |
6 | 00858012005496 | 720269 | AG3030 | Vaginal Applicator 30 mm | JAD | System, Therapeutic, X-Ray | 2 | Vaginal Applicator, 30mm |
7 | 00858012005410 | 720297 | SK3510 | Surface Applicator End Cap, 10 mm, 10-Pack | JAD | System, Therapeutic, X-Ray | 2 | (10) Applicator End Cap, 10 mm |
8 | 00858012005373 | 710707 | F5350-4 | Rigid Shield 4 cm | JAD | System, Therapeutic, X-Ray | 2 | Rigid Shield 4 cm |
9 | 00858012005342 | 720343 | AB2063E | Balloon Applicator, 5x7 cm Ellipsodial | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
10 | 00858012005335 | 720332 | AB2062 | Balloon Applicator, 5-6 cm Spherical | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
11 | 00858012005328 | 720331 | AB2061 | Balloon Applicator, 4-5 cm Spherical | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
12 | 00858012005311 | 720342 | AB2060 | Balloon Applicator, 3-4 cm Spherical | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
13 | 00858012005250 | V1.1 | DSC014-02-EU | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection and SLD, GE |
14 | 00858012005236 | V1.1 | DSC014-01-EU | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection and SLD, GE |
15 | 00858012005229 | V1.1 | DSC014-01-US | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection and SLD, GE |
16 | 00858012005205 | V2.1 | D70124, D70141 and D70126 | PowerLook Density Assessment is a software application intended for use with dig PowerLook Density Assessment is a software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. | LLZ | System, Image Processing, Radiological | 2 | iReveal Breast Density Assessment |
17 | 00858012005168 | DSC010-08 | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD Planmed | ||
18 | 00850008977237 | DSC018-07 | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ 4GPU Tower Platform, US | ||
19 | 00850008977190 | DSC012-03 | LLZ | System, Image Processing, Radiological | 2 | PowerLook AMP with Density Assessment GE OUS | ||
20 | 00850008977084 | DSC011-03-US | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook 10 PRO+, Rack Mount, US | ||
21 | 00858012005960 | 2.1 | QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 2 | ProFound AI | ||
22 | 00858012005823 | V7.2 | DSC017-03-ROW | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO Hardware Upgrade, SLD |
23 | 00858012005809 | V7.2 | DSC017-02-ROW | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO Hardware Upgrade, SLD |
24 | 00858012005793 | V7.2 | DSC017-02-US | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO Hardware Upgrade, SLD |
25 | 00858012005588 | 720772 | F5201 | Flexishield Radiation Absorber, Box | KPY | Shield, Protective, Personnel | 1 | Flexishield Radiation Absorber |
26 | 00858012005694 | 720818 | F5410-15 | Packaged Cutout 15 mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 15 mm, xFlex |
27 | 00858012005526 | 750850 | XP1200 | Axxent Surface Controller | JAD | System, Therapeutic, X-Ray | 2 | Axxent Surface Controller |
28 | 00858012005519 | 750050 | XP1100 | Axxent Standard Controller | JAD | System, Therapeutic, X-Ray | 2 | Axxent Standard Controller |
29 | 00858012005403 | 710710 | F5350-7 | Rigid Shield 7 cm | JAD | System, Therapeutic, X-Ray | 2 | Rigid Shield 7 cm |
30 | 00858012005304 | 720697 | S7551 | Axxent HDR X-Ray Source 50 cm HUT | JAD | System, Therapeutic, X-Ray | 2 | HDR X-ray Source 2.2 |
31 | 00858012005298 | 720684-02 | S7601 | Axxent HDR X-Ray Source 25 cm ESL | JAD | System, Therapeutic, X-Ray | 2 | HDR X-ray Source 2.2 |
32 | 00858012005281 | 720684 | S7501 | Axxent HDR X-Ray Source 25 cm HUT | JAD | System, Therapeutic, X-Ray | 2 | HDR X-ray Source 2.2 |
33 | 00858012005267 | V1.1 | D4D0181 | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection FRU |
34 | 00858012005243 | V1.1 | DSC014-02-US | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO with Tomo Detection, Upgrade, GE |
35 | 00858012005175 | DSC010-09 | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD Agfa CR | ||
36 | 00858012005113 | DSC010-03-EU | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD Siemens OUS | ||
37 | 00850008977145 | DSC018-06 | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ Rack-Mount, US | ||
38 | 00850008977244 | DSC018-07-UP | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ 4GPU Tower Upgrade, US | ||
39 | 00850008977121 | DSC018-04 | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ Hardware Platform GE, US | ||
40 | 00858012005939 | V2 | QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 2 | PowerLook Tomo Detection (ProFound AI) | ||
41 | 00858012005861 | V7.2 | D4D0192 | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO with SLD, FRU |
42 | 00858012005762 | 720825 | F5410-KIT | Packaged Cutout set,xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout set,xFlex |
43 | 00858012005731 | 720822 | F5410-27 | Packaged Cutout 27 mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 27 mm, xFlex |
44 | 00858012005717 | 720820 | F5410-22 | Packaged Cutout 22.2 mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 22.2 mm, xFlex |
45 | 00858012005595 | 710339 | SK1000 | Surface Applicator Set | JAD | System, Therapeutic, X-Ray | 2 | Surface Applicator Set |
46 | 00858012005472 | 720267 | AG3020 | Vaginal Applicator 20 mm | JAD | System, Therapeutic, X-Ray | 2 | Vaginal Applicator, 20mm |
47 | 00858012005427 | 720298 | SK3520 | Surface Applicator End Cap, 20 mm, 10-Pack | JAD | System, Therapeutic, X-Ray | 2 | (10) Applicator End Cap, 20 mm |
48 | 00858012005274 | 710706 | F5350-3 | Rigid Shield 3 cm | JAD | System, Therapeutic, X-Ray | 2 | Rigid Shield 3 cm |
49 | 00858012005212 | V1.1 | DS0244, D70130 | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook Tomo Detection Software |
50 | 00858012005090 | DSC010-01-EU | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD GE OUS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04056481144265 | 1.1 | Buzz Virtual App | BRAINLAB AG | ||
2 | 04056481143527 | 4.3 | DICOM Proxy | BRAINLAB AG | ||
3 | 04056481143305 | 15800A | Buzz 2.0 | BRAINLAB AG | ||
4 | 04056481143046 | 15501 | Buzz Virtual | BRAINLAB AG | ||
5 | 04056481143039 | 15790 | Buzz Compact | BRAINLAB AG | ||
6 | 04056481142810 | 3.1 | 39010 | QUENTRY SUBSCRIPTION | BRAINLAB AG | |
7 | 04056481140977 | 15800 | Buzz 2.0 | BRAINLAB AG | ||
8 | 04056481140519 | 4.1 | DICOM Proxy | BRAINLAB AG | ||
9 | 04056481139049 | 4.0 | 30074-03S | DICOM Proxy 4.0 | BRAINLAB AG | |
10 | 04056481138226 | 3.4 | 30074-03O | DICOM Proxy | BRAINLAB AG | |
11 | 04056481132224 | 3.4 | 30074-03N | DICOM Proxy | BRAINLAB AG | |
12 | 04049539103512 | Model II | CALLISTO eye Panel PC | CARL ZEISS MEDITEC AG | ||
13 | 04048551418147 | WM200 | OR1 SmartScreen | SMARTSCREEN | KARL STORZ GMBH & CO. KG | |
14 | 03770019599013 | v1.2.0 | inHEART Models Shaper is a medical image processing and visualization software f inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs.inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions. | inHEART Models Shaper | INHEART | |
15 | 03770019599006 | v2.2.1 | inHEART Models Explorer is a web-based visualization software for display, revie inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs.inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions. | inHEART Models Explorer | INHEART | |
16 | 00866389000129 | C-Arm Kit | The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS ( The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS (Galileo Positioning System) & GPS Tablet that is used to wirelessly send images from a video source such as a C-Arm to the Radlink GPS or GPS Tablet. The Radlink Wireless C-Arm Kit is a computer system that accepts video signals from BNC, VGA, or DVI connections and converts these signals into an image file, which is then sent wirelessly to a Radlink GPS or GPS Tablet. | Radlink Wireless C-Arm Kit | RADLINK, INC. | |
17 | 00865885000220 | ShowCase Viewer for iPad | ShowCase Viewer for iPad is a DICOM medical image viewer for the Apple iPad. Sho ShowCase Viewer for iPad is a DICOM medical image viewer for the Apple iPad. ShowCase Viewer for iPad is not intended for diagnostic use. | SHOWCASE® | TRILLIUM TECHNOLOGY, INC. | |
18 | 00860006066307 | MS-100-1001 | MediScout® is an augmented reality accessory to clinical ultrasound (US) systems MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration. | MediScout system | MEDIVIEW XR, INC. | |
19 | 00860002800301 | 01 | Apollo arcc® is a Health Information System facilitating the combination of pati Apollo arcc® is a Health Information System facilitating the combination of patient information received from another information system (HL7 interface) with clinical multimedia (images, video, audio and other formats) and clinical information in a highly organized and secure environment. Patient information may also be entered directly into arcc. The workflow is representative of standard clinical specialties including but not limited to pathology, gastroenterology, dermatology, surgery, etc. Digital media can be imported via TCP/IP or via digital capture through direct connection to a modality device (Ex. would be a microscope mounted camera). | arcc | APOLLO ENTERPRISE IMAGING CORP | |
20 | 00860002304540 | 1.0.0 | Software that provides standardized metadata descriptions of diagnostic medical Software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series. | Curie ENDEX | ENLITIC, INC. | |
21 | 00860002304533 | 1.0.0 | Standardize is software that provides standardized metadata descriptions of diag Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series. | Standardize | ENLITIC, INC. | |
22 | 00860002304526 | 1.0.0 | The Curie product is a software platform that hosts applications related to vari The Curie product is a software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user access and security, and allows for integrations with other devices such as third-party PACs systems. | Enlitic Curie | ENLITIC, INC. | |
23 | 00860001554533 | DOCS | DOCS system is an audio/video integration system that is installed in health car DOCS system is an audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures. | DOCS | CV MEDICAL, LLC | |
24 | 00860001554526 | U | The NuBOOM/DOCS system is an equipment management and audio/video integration sy The NuBOOM/DOCS system is an equipment management and audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The NuBOOM/DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures.The NuBOOM/DOCS system consists of two major components: an equipment management subsystem and a video integration subsystem.The equipment management subsystem—called the NuBOOM—is a metal superstructure (cabinet) that is anchored to the facility floor. The cabinet provides an attachment point for booms, which support adjustable arms with flat-panel monitors, and shelves for storage of medical equipment. The booms and spring arms can be moved to allow the most ergonomic placement of the flat-panel monitors. The equipment management component of the NuBOOM/DOCS system provides health care staff with an adjustable system that can be configured to the needs of each procedure. | NuBOOM | CV MEDICAL, LLC | |
25 | 00860001554519 | NuCART | The NuCART® is a mobile display and image management platform intended to be use The NuCART® is a mobile display and image management platform intended to be used by health care providersin Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signalsfrom source devices to monitors. It is tailored for use with a C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. | NuCART | CV MEDICAL, LLC | |
26 | 00860001554502 | NuVIEW | The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and Patient Monitor in Minimally Invasive Surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. Designed for mobility and simplicity it will compete with entry level mobile carts. The NuVIEW® product is comprised of Mechanical and Hardware design inputs. | NuVEIW | CV MEDICAL, LLC | |
27 | 00859873006066 | 2 | The GOLD™ Lx is a client-server distribution image storage and communication sys The GOLD™ Lx is a client-server distribution image storage and communication system whose intended use is to provide solutions for hospital and related institutions/sites, which will store, retrieve, and distribute medical images and data from vendor modalities and hospital information systems. | GOLDLx | HERMES MEDICAL SOLUTIONS AB | |
28 | 00859873006011 | 1.6 | The GOLD™ Lx is a client-server distribution image storage and communication sys The GOLD™ Lx is a client-server distribution image storage and communication system whose intended use is to provide solutions for hospital and related institutions/sites, which will store, retrieve, and distribute medical images and data from vendor modalities and hospital information systems. | GOLD Lx | HERMES MEDICAL SOLUTIONS AB | |
29 | 00859151005255 | MVR400Z | MVR400Z | MediCap | MEDICAPTURE, INC. | |
30 | 00859151005170 | MVR408 | MVR408 | MVR | MEDICAPTURE, INC. | |
31 | 00859151005156 | MVC410 | MVC410 - MVC Pro SDI to HDMI Converter | MVC | MEDICAPTURE, INC. | |
32 | 00859151005132 | MVR420 | MVR420 | MVR | MEDICAPTURE, INC. | |
33 | 00859151005101 | MVR409 | MVR409 | MVR | MEDICAPTURE, INC. | |
34 | 00859151005033 | MVR400 | MVR400 | MVR | MEDICAPTURE, INC. | |
35 | 00859151005026 | USB170 | USB170 | MediCap | MEDICAPTURE, INC. | |
36 | 00859151005019 | USB300 | USB300 | MediCap | MEDICAPTURE, INC. | |
37 | 00859151005002 | USB200 | USB200 | MediCap | MEDICAPTURE, INC. | |
38 | 00858012005977 | 9.1 | PowerLook | ICAD, INC. | ||
39 | 00858012005946 | V9 | PowerLook | ICAD, INC. | ||
40 | 00857534006646 | Application Platform 4.0 KIT | Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000 | VISIUSmatrix | DEERFIELD IMAGING, INC. | |
41 | 00857534006639 | Application Platform 4.0- KIT | Applications Platform 4.0 US/JPN – INT KIT-120085-000 | VISIUSmatrix | DEERFIELD IMAGING, INC. | |
42 | 00857534006622 | Application Platform 4.0- 3 Room | Applications Platform 4.0 US/JPN – 3 Room- 119897-000 | VISIUSmatrix | DEERFIELD IMAGING, INC. | |
43 | 00857534006493 | Application Platform 4.0 2-Room | Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000 | VISIUSmatrix | DEERFIELD IMAGING, INC. | |
44 | 00853866003995 | 7.12.6 | The Vitrea Advanced Visualization software is a medical diagnostic system that a The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server | Vitrea Advanced Visualization | CANON MEDICAL INFORMATICS, INC. | |
45 | 00853866003988 | 7.14.2 | The Vitrea Advanced Visualization software is a medical diagnostic system that a The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server | Vitrea Advanced Visualization | CANON MEDICAL INFORMATICS, INC. | |
46 | 00853866003971 | 7.12.5 | The Vitrea Advanced Visualization software is a medical diagnostic system that a The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server | Vitrea Advanced Visualization | CANON MEDICAL INFORMATICS, INC. | |
47 | 00853866003964 | 7.7.1 | Vitrea View software is a web-based, cross-platform, zero-footprint enterprise i Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and Multi-Media medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images from a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data with access to clinical reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians, clinicians and other medical professionals. The Vitrea View software is scalable due to the web-based zero-footprint architecture which allows sites to quickly and easily add new users as demand grows. The software may also be deployed in a virtualized environment. | Vitrea View | CANON MEDICAL INFORMATICS, INC. | |
48 | 00853866003957 | 7.12.4 | The Vitrea Advanced Visualization software is a medical diagnostic system that a The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server | Vitrea Advanced Visualization | CANON MEDICAL INFORMATICS, INC. | |
49 | 00853866003940 | 7.14.1 | The Vitrea Advanced Visualization software is a medical diagnostic system that a The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server | Vitrea Advanced Visualization | CANON MEDICAL INFORMATICS, INC. | |
50 | 00853866003919 | 7.7 | Vitrea View software is a web-based, cross-platform, zero-footprint enterprise i Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and Multi-Media medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images from a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data with access to clinical reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians, clinicians and other medical professionals. The Vitrea View software is scalable due to the web-based zero-footprint architecture which allows sites to quickly and easily add new users as demand grows. The software may also be deployed in a virtualized environment. | Vitrea View | CANON MEDICAL INFORMATICS, INC. |