# K100335: Ors Visual

- Pathway: 510(k) (Traditional)
- Applicant: Object Research Systems, Inc.
- Decided: Apr 8, 2010 after 62 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ORS Visual is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM compliant image data derived from various; sources including CT and MRI. The ORS Visual software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physiclan, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software Is installed on appropriate hardware and that image quality is suitable for the clinical application. Object Research Systems (ORS) recommends that users of the ORS Visual software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied. Mammographic and compressed images are not supported for viewing. The software is not Intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that Is near or smaller than the scanning resolution may be present. ORS Visual software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of ORS Visual are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Source page: https://510kreport.com/device/K100335
Methodology: https://510kreport.com/methodology