# K213975: KEOPS Balance Analyzer 3D

- Pathway: 510(k) (Traditional)
- Applicant: S.M.A.I.O
- Decided: May 6, 2022 after 137 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: 12 generations back to K896095 (1990). 25 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141669: Surgimap, Nemaris, Inc. (2014) Summary page 4.
- K180091: UNiD Spine Analyzer, Medicrea International (2018) Summary page 4.

## Most influential descendants
- K223841: KBA3D (2023), 1 descendant of its own
- K261500: KBA3D (v2.4.0) (2026), 0 descendants of its own

## Indications for use
The KEOPS Balance Analyzer 3D is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K213975
Methodology: https://510kreport.com/methodology