# K122429: Vessel Analysis and Autoplaque for Ors Visual

- Pathway: 510(k) (Traditional)
- Applicant: Object Research Systems (Ors), Inc.
- Decided: Nov 28, 2012 after 111 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
Longest line of descent: 10 generations back to K913770 (1991). 67 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool, Philips Medical Systems (Cleveland), Inc. (2009) Summary page 2.
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 2.
- K060779: Advance Vessel Analysis II, GE Healthcare (2006) Summary page 6.

## Most influential descendants
- K190868: Cleerly Labs (2019), 7 descendants of its own
- K202280: Cleerly Labs v2.0 (2020), 5 descendants of its own
- K212758: Autoplaque (2023), 3 descendants of its own
- K242338: Cleerly LABS (v2.0) (2025), 2 descendants of its own
- K242240: CaRi-Plaque (2025), 1 descendant of its own

## Indications for use
Vessel Analysis is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Vessel Analysis is a post processing application option for the ORS Visual (K1 00335) platform family of products and can be used in the analysis of 20/3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent procedure and directional vessel tortuosity visualization. Vessel Analysis automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure areas of abnormalities within a vessel. 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 (Kl100335) and the Vessel Analysis add-on 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 Vessel Analysis and ORS Visual (Kl 00335) are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Source page: https://510kreport.com/device/K122429
Methodology: https://510kreport.com/methodology