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510(k) Data Aggregation
K Number
K141561Device Name
VM PACS WITH VM MEDICAL WORKSTATION
Manufacturer
Date Cleared
2015-01-16
(218 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VISUAL MEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
VM PACS with VM Medical Workstation is a software designed to receive, store, distribute, process and display Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data throughout a clinical environment. The software performs digital communication and storage of the images and is meant to be administrated by a trained user.
VM Medical Workstation and VM Clinical Viewer are both softwares capable to perform image processing, measurement and other diagnostics tools, it is designed to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
VM PACS is designed to Store Medical Dicom Images and leave them available to be used for diagnostics or transferred to other Dicom devices.
VM PACS is not meant to create or modify DICOM images. VM PACS store the images and the Data Set send by an DICOM compatible image diagnostic equipment and store them making them available to be access by a workstation or viewer, or been transfer to another Dicom Compatible device.
VM PACS does not modify the images store in it.
User Graphic interface VM Medical Workstation is a complete Workstation which provides diagnostic tools for image diagnose, for CT, MR, PT, CR, DX, NM, MG, XA, RF, SC, US and ES, as zoom, Window & Level variation and presets, measurements and a complete set of diagnostics tools and includes a report tool for the studies.
Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
VM Clinical Viewer is the web access interface of VM PACS, which allows integration with any Operating System, brings to the institution the capacity to access the images remotely.
VM Clinical Viewer allows the specialist consultation and the communication between radiologists and referring physicians. The system enables authorized external users to have access to specific patient studies, is not intended for diagnostic purposes when used on mobile devices.
Device Description
VM PACS with VM Medical Workstation is a software composed by a Picture Archiving and Communication System able to receive, transfer and display Dicom Images acquired and send by imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices, along with a Graphic interface used to configure the PACS and diagnose Medical Images Stored in it.
VM PACS is an affordable and scalable Picture Archiving and Communication System designed to optimize imaging workflow and simplify image management. Use a powerful database engine as client server data. The system architecture scalable, allowing to add storage media according to the volume of studies intended to store and be access online. This gives the possibility to increase gradually the investment in hardware storage as needed. All Image Storage and communications are according to the Dicom Standard. A configuration interface allows the system administrator to set the Application Entity Title (AE-TITLE) and listening port for the Dicom Communications with other devices. To protect the studies PACS has a full-featured fully automatic and programmable backup instance. VM PACS is capable to send query and retrieve studies from other Dicom Applications using the DICOM standard. For Monitoring the Dicom traffic, incorporating a tool which shows all the DICOM transfers in a lapse of time, also VM PACS can be set to auto send studies to other Dicom Application Entities (AEs), depending on the modality, the description, the patient, or any other Dicom Tag selected and also can send all the previous studies from the same patient to a tarqet Dicom AE.
VM Medical Workstation provides all the necessary tools needed for image diagnosis. VM Medical WS allows the user to visualize; report and print images and studies, whit a complete set of tools designed for diagnose medical images. VM Medical Workstation includes a report module to archive the diagnostic results, linked to the informed study. VM Medical WS allows the authorized user to burn studies in a CD/DVD along with the study have an autorun software with diagnostic Dicom tools. If the study has a report, this report is attached to the CD/DVD in a PDF format. The software also include an Advance Printing tool which allows the user to perform a personalized layout, changing window & Level, zoom, and pan to one or all images in the layout.
VM Clinical Viewer is the diagnostic web access interface of VM PACS, which allows integration with any Operating System, and allows the institution to access the images remotely. VM Clinical Viewer improves the specialist consultation and the communication between radiologists and referring physicians from any location in the world. The system enables authorized external users to have access to specific patient studies. VM Clinical Viewer is not intended to be use with diagnostics proposes in mobile devices.
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K Number
K090295Device Name
BODYVIZ, MODEL 100
Manufacturer
Date Cleared
2009-03-04
(27 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VISUAL MEDICAL SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BodyViz is a software device that receives digital images and data from various sources (i.e. CT scanner, MRI scanners). Data must be in DICOM format. Images and data are parsed, stored, processed, and displayed within the system as 3D representations. Image tools are available such as translation, rotation, scaling, clipping, and coloring. A data tool is available to window the displayed representation to certain tissue types based on tissue density (e.g., muscle, bone, or skin). Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.
Device Description
BodyViz is a software based application for creating 3D models of patient data from 2D scan slices. Users have the ability input, display, color, and manipulate the 2D scan slices via a 3D representation. BodyViz is a visualization environment that allows surgeons to plan various types of surgery on their patient data in 3D. BodyViz works with any, DICOM formatted 2D image scan slices. Data can be accessed from internal and external data storage devices, as well as network and CD/DVD data sources. The software runs on any modern Windows based computer (i.e. laptop or desktop) with a 3D graphics card that meets minimum requirements, eliminating the need for specialized hardware. BodyViz is a medical device image software that is used with computer hardware in a typical hospital or clinic networked computer environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing sufficient opportunity for competent human intervention, interprets images and information being displayed.
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K Number
K012097Device Name
VORTEX
Manufacturer
Date Cleared
2001-07-12
(7 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ULTRAVISUAL MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The system is designed to provide image storage, display, and workflow integration. The image display architecture provides capabilities for near-realtime capabilities for radiologists as well as image reviewing workgroup members and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.
Device Description
UltraVisual Vortex™ is an integrated client-server software package, which may be marketed as software only, that is used in conjunction with standard PC hardware. UltraVisual Vortex™ is a PC-based, DICOM-compliant PACS device that is able to receive, transmit and display DICOM images over both local and wide area network. Images sent to the UltraVisual Vortex™ server are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by UltraVisual Vortex™ to create JPEG and wavelet images follow known and accepted protocols.
Vortex™ can be used within a hospital, a managed care facility or an isolated imaging center. It can also be used for image distribution over the network for teleradiology/review purpose.
UltraVisual Vortex™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.
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