DEVICE: Vessel Analysis for ORS Visual (B332VIVA0100)
Device Identifier (DI) Information
Vessel Analysis for ORS Visual
ORS-VISU-VA01
In Commercial Distribution
Object Research Systems (ORS) Inc
ORS-VISU-VA01
In Commercial Distribution
Object Research Systems (ORS) Inc
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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41670 | Radiological PACS software |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K122429 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
1b18f1de-935a-4213-8e5a-6dcbeec1843f
October 18, 2023
6
September 15, 2016
October 18, 2023
6
September 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
514 843-3861
info@theobjects.com
info@theobjects.com