DEVICE: ORS Visual (B332VISU0105)

Device Identifier (DI) Information

ORS Visual
ORS-VISU-0105
In Commercial Distribution

Object Research Systems (ORS) Inc
B332VISU0105
HIBCC

1
240758818 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radiology picture archiving and communication system application software An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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FDA Product Code

[?]
Product Code Product Code Name
LLZ System, Image Processing, Radiological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100335 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9a1c17cf-b51b-483c-b933-44c5a671c546
July 06, 2018
3
September 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
514-843-3861
info@theobjects.com
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