# K192435: NuVasive NuvaLine

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Sep 26, 2019 after 21 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: 13 generations back to K842956 (1984). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162647: NuVasive NuvaLine Mobile App, Nu Vasive, Incorporated (2017) Summary page 4.

## Indications for use
NuVasive NuvaLine is a medical device software application intended to assist healthcare professionals in capturing, viewing, measuring, and storage and distribution of spinal alignment assessment images at various time points in patient care. Online synchronization of the database allows healthcare professionals and service providers to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on various platforms. Clinical judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K192435
Methodology: https://510kreport.com/methodology