# K172327: VMA™ System version 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Kinematics, Inc.
- Decided: Aug 25, 2017 after 24 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: 6 generations back to K942948 (1995). 9 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133875: The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion Normalizer Patient Handling and Data, Ortho Kinematics, Inc. (2014) Summary page 4.

## Most influential descendants
- K192109: KOALA (2019), 6 descendants of its own
- K203696: RBknee (2021), 2 descendants of its own
- K223621: DeepXray (2023), 1 descendant of its own
- K223646: IB Lab LAMA (2023), 1 descendant of its own
- K253172: MediAI-OA (2026), 0 descendants of its own

## Indications for use
The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are acquired with the assistance of the MOTION NORMALIZER patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and motion of selected objects, such as bone structures, can be generated and presented in the form of a ‘motion analysis’ report containing graphics, charts, and text.

Source page: https://510kreport.com/device/K172327
Methodology: https://510kreport.com/methodology