Autoplaque for ORS Visual

Primary DI
B332VIAP0100
Brand
Autoplaque for ORS Visual
Company
Object Research Systems (ORS) Inc
Model
ORS-VISU-AP01
Device description
Autoplaque is a post-processing add-on module for ORS Visual that provides automated quantification of calcified and non-calcified plaque lesions in coronary arteries from contrasted coronary CT angiographic studies for the evaluation of cardiovascular disease. Users can automatically segment the section of the coronary artery of interest, or manually input the centerline, to initiate a detailed and robust plaque lesion analysis routine. Analysis by Autoplaque provides biometric information that includes calcified plaque volume, non-calcified plaque volume with possible separation into low and high density non-calcified plaques, stenosis percentage, remodeling index, plaque length measurement, and proximal, distal, and stenosis diameters. If the Autoplaque add-on is used to analyze more than one coronary artery section, the additional parameters of total non-calcified plaque volume, total low density plaque volume, total calcified plaque volume, maximum remodeling index, maximum stenosis percentage, and the maximum plaque length will also be available.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
B332VIAP0100PrimaryHIBCC0

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
B332VISU0105ORS VisualORS-VISU-01052016-09-15
B332VIVA0100Vessel Analysis for ORS VisualORS-VISU-VA012016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
00860012615315Denti.AI DetectDenti.AI Technology IncLLZ2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05