Vessel Analysis for ORS Visual

Primary DI
B332VIVA0100
Brand
Vessel Analysis for ORS Visual
Company
Object Research Systems (ORS) Inc
Model
ORS-VISU-VA01
Device description
Vessel Analysis is a post-processing add-on module for ORS Visual that enables radiologists, cardiologists, vascular surgeons, and interventionalists to quickly and confidently evaluate CT angiographic studies. Vessel Analysis provides stenosis calculations, aneurysm quantification, and stent and stent-graft planning of the aorta, carotid, and renal arteries in an easy-to-use, intuitive screen that can simplify the clinical task of planning endovascular procedures. Advanced functionality such as automated vessel finding acts as a baseline for accurate vessel measurements and permits rapid segmentation of vessels.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.
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
K122429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122429000VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUALObject Research Systems (Ors), Inc.2012-11-28LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B332VIVA0100PrimaryHIBCC0

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
B332VISU0105ORS VisualORS-VISU-01052016-09-15

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