# K220146: VisAR

- Pathway: 510(k) (Traditional)
- Applicant: Novarad Corporation
- Decided: May 27, 2022 after 128 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K924630 (1993). 56 ancestors in all.
No later device cites it as a predicate yet.
2 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190929: xvision Spine system (XVS), Augmedics, Ltd. (2019) Summary page 4.
- K172418: OpenSight, Novarad Corporation (2018) Summary page 4.

## Indications for use
The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.

Source page: https://510kreport.com/device/K220146
Methodology: https://510kreport.com/methodology