# K172418: OpenSight

- Pathway: 510(k) (Traditional)
- Applicant: Novarad Corporation
- Decided: Sep 21, 2018 after 407 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: 9 generations back to K924630 (1993). 49 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170167: True 3D Viewer Software, Echopixel, Inc. (2017) Summary page 4.
- K163622: Lung Vision, Bodyvision Medical, Ltd. (2017) Summary page 4.

## Most influential descendants
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own
- K213128: IntraOp VSP Software Device (2022), 1 descendant of its own
- K243069: Lumys (V1) (2025), 0 descendants of its own
- K232189: OrionXR (2023), 0 descendants of its own
- K220146: VisAR (2022), 0 descendants of its own

## Indications for use
OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for pre-operative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation. OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis. OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures. OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand anatomy and pathology of patient.

Source page: https://510kreport.com/device/K172418
Methodology: https://510kreport.com/methodology