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510(k) Data Aggregation
K Number
K121447Device Name
ISCHEMA VIEW RAPID
Manufacturer
ISCHEMA VIEW, INC.
Date Cleared
2013-10-04
(507 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ISCHEMA VIEW, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices.
iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data.
The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Device Description
RAPID is a software package that provides for the visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT (Computed Tomography) and MRI (Magnetic Image Resonance). RAPID can be installed on a customer PC or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities.
RAPID works with the following types of (DICOM compliant) medical image data:
- · CT (Computed Tomography)
- · MRI (Magnetic Image Resonance)
RAPID acquires (DICOM compliant) medical image data from the following sources:
- · DICOM file
- · DICOM CD-R
- · Network using DICOM protocol
RAPID provides tools for performing the following types of analysis:
- · volumetry of threshold maps
- · time intensity plots for dynamic time courses
- measurement of mismatch between labeled volumes on co-registered image volumes
RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server). The RAPID Server is an image processing engine that connects to a hospital LAN, inside the Hospital Firewall. It can be a dedicated RAPID Server or a vmRAPID appliance, which is a virtualized RAPID Server that runs on a dedicated hospital server. Where available, the RAPID Server is placed logically in the demilitarized zone (DMZ) of the hospital's network to facilitate bidirectional secure connection between the (local) RAPID Server and the centralized iSchemaView Server.
The RAPID Server is configured to connect to applicable DICOM devices (PACS, Imaging Modalities, Research Workstations) via the hospital LAN and to receive diffusion and perfusion (DICOM) data directly and automatically from imaging modalities as they become available. It processes acquired data and delivers postprocessed images directly back to imaging modalities, local PACS and/or workstations, again using DICOM communication. It also transmits data to the iSchemaView Server for storage, retrieval and viewing.
The iSchemaView Server is a dedicated server that provides a central repository for RAPID data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing RAPID data. It connects to a firewalled Data Center Network and has its own firewall for additional data security. The iSchemaView Server connects to one or more RAPID Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).
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