# K222757: Clarus Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Viewer Corporation
- Decided: Feb 24, 2023 after 165 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: 6 generations back to K924630 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210726: ImmersiveTouch, Immersivetouch, Inc. (2021) Summary page 5.

## Indications for use
Clarus Viewer® Version 1.0 is a software solution intended to be used for viewing, manipulation, communication, storage, 3D-visualization, and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports images and anatomical datasets, limited to CT and MR. Clarus Viewer® supports the interpretation and evaluation of examinations and follow-up documentation of findings within healthcare institutions, for example, in Radiology and other Medical Imaging environments. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings. Note: The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. Clarus Viewer is a complement to these standard procedures. Clarus Viewer® is not intended for the displaying of digital mammography images for diagnosis.

Source page: https://510kreport.com/device/K222757
Methodology: https://510kreport.com/methodology