# K252091: Surgical Reality Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Medicalvr B.V.
- Decided: Jan 29, 2026 after 210 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 11 generations back to K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222676: Ceevra Reveal 3, Ceevra, Inc. (2023) Summary page 5.

## Indications for use
Surgical Reality Viewer is a medical imaging visualization software intended to assist trained healthcare professionals with preoperative and intraoperative visualizations, by displaying 2D and 3D renderings of DICOM compliant patient images and normal anatomic segmentations derived from patient images as well as functions for manipulation of segmentations and 3D models. Surgical Reality Viewer assists the trained healthcare professional who is responsible for making all final patient management decisions. The machine learning algorithms in use by Surgical Reality Viewer are intended for use on adult patients aged 22 years and over.

Source page: https://510kreport.com/device/K252091
Methodology: https://510kreport.com/methodology