# K230463: NSite Scoliosis Assessment App

- Pathway: 510(k) (Traditional)
- Applicant: Nsite, Inc.
- Decided: Nov 15, 2023 after 267 days
- Product code: LDK (Device, Sensing, Optical Contour)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923792 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923792: Quantec Spinal Measuement System, Quantec Image Processing, Ltd. (1994) Summary page 5.

## Indications for use
The NSite Scoliosis Assessment App is intended as an adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations based on a calculated Asymmetry Index for patients with or at risk for idiopathic scoliosis, which will yield an output of low or high risk of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees.

Source page: https://510kreport.com/device/K230463
Methodology: https://510kreport.com/methodology