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ORS Visual

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100335

by Object Research Systems, Inc.

Identifiers

510(k) Number
K100335 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ORS Visual is a proprietary software application 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.

The device is supplied as software and is used by researchers and scientists for advanced visualization techniques, configurable view layouts, and navigation through single or multiple datasets in single or multiple view windows. It received FDA 510(k) clearance (K100335) on April 8, 2010, and is classified under product code LLZ with advisory committee review in Radiology.

Frequently asked questions

What is ORS Visual used for?

ORS Visual is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities, enabling communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data for research and scientific applications.

How is ORS Visual supplied and what type of device is it?

ORS Visual is supplied as a software application and is used by researchers and scientists for advanced visualization techniques, configurable view layouts, and navigation through single or multiple datasets in single or multiple view windows.

What regulatory clearance does ORS Visual have and when was it granted?

ORS Visual received FDA 510(k) clearance (K100335) on April 8, 2010, and is classified under product code LLZ with advisory committee review in Radiology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ORS Visual SI - Meyer Instruments, Object Research Systems (ORS) Inc ORS-VISU-0105 ORS Visual, ORS Visual - Pricing, Features, and Details in 2026 - SoftwareSuggest

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Object Research Systems, Inc.

Sources (1)

  • FDA 510(k) K100335 24 fields · synced Sep 27, 2026