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Vessel Analysis for ORS Visual

FDA UDI

Class II (US FDA UDI)

by Object Research Systems (Ors), Inc.

Identity

Trade Name
Vessel Analysis for ORS Visual FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
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. FDA UDI
Model / Reference
ORS-VISU-VA01 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B332VIVA0100 FDA UDI
510(k) Number
K122429 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiological PACS software

Vessel Analysis for ORS Visual by Object Research Systems (Ors), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

Cleared under the same submission

K122429 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Object Research Systems (Ors), Inc.

Sources (1)

  • FDA UDI 1b18f1de-935a-4213-8e5a-6dcbeec1843f 35 fields · synced May 30, 2026