ORS Visual

Primary DI
B332VISU0105
Brand
ORS Visual
Company
Object Research Systems (ORS) Inc
Model
ORS-VISU-0105
Device description
ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware. Available functions include DICOM communication, display of 2D images in orthogonal and oblique planes, computation and display of rendered 3D images and maximum intensity projections (MIPs), and 2D and 3D image measurements. The user interface follows typical clinical workflow patterns that include searching for patient data, reviewing and analyzing digital images, and reporting findings. The user controls these functions with normal mouse-click conventions, a system of context-based tools, and on-screen prompts. A standard layout for image display, navigation, and information is used throughout the application.ORS Visual also offers users two separate add-on modules to address specific vascular clinical functionalities: Vessel Analysis, an add-on solution for vascular analysis and stent-graft planning of CTA studies, and Autoplaque, a cardiac plaque and lesion quantification tool.
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100335000ORS VISUALObject Research Systems, Inc.2010-04-08LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B332VISU0105PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system application softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
514-843-3861info@theobjects.com

Regulatory Flags#

DUNS number
240758818
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B332VIAP0100Autoplaque for ORS VisualORS-VISU-AP012016-09-15
B332VIVA0100Vessel Analysis for ORS VisualORS-VISU-VA012016-09-15

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