# K120288: Orthocad Software Option

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Sep 19, 2012 after 232 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 K911667 (1991). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111803: G-SCAN, Esaote, S.p.A. (2011) Summary page 3.
- K103475: Spineanalyer Model Sapoc, Optasia Medical (2011) Summary page 1.

## Indications for use
OrthoCAD is an option that provides the morphometry of the lumbo-sacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis.

Source page: https://510kreport.com/device/K120288
Methodology: https://510kreport.com/methodology