# K221344: nView s1 with nav option

- Pathway: 510(k) (Traditional)
- Applicant: Nview Medical
- Decided: Dec 28, 2022 after 233 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K003266 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211064: nView s1 with nav option, Nview Medical (2021) Summary page 4.

## Indications for use
The nView sl is intended as an imaging system to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities. The nView sl is indicated to image human anatomy up to 30 cm thickness. The nView sl is not indicated for mammographic or lung nodule applications. The nView sl with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediatric populations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView sl images of the anatomy.

Source page: https://510kreport.com/device/K221344
Methodology: https://510kreport.com/methodology