# K240793: MSKai

- Pathway: 510(k) (Traditional)
- Applicant: Mskai
- Decided: Dec 16, 2024 after 269 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 18 generations back to K971684 (1997). 194 ancestors in all.
No later device cites it as a predicate yet.
5 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220497: CoLumbo, Smart Soft Healthcare AD (2022) Summary page 5.
- (no number) AI-Rad Companion (Cardiovascular): named in the summary without a submission number

## Indications for use
MSKai is an image identification, post-processing, measurement, and reporting software tool that provides qualitative viewing and quantitative spine measurements from previously-acquired T 2 weighted DICOM lumbar spine Magnetic Resonance Imaging (MRI) images for users' review, evaluation and analysis. It provides the following functionality to assist users in identifying, observing, measuring and reporting measurements: - Anatomy segmentation; - Anatomy labeling; - Anatomy measurement; and - Export of measurement results to a qualitative and quantitative report for user's evaluation, amendment and authorization MSKai does not serve as a diagnostic device by providing or recommending any type of medical diagnosis or treatment. MSKai simply provides users the ability to access objective and repeatable identification, segmentation, measurement and reported measurements of the Lumbar spine. The user is responsible for the indications of preferences and settings, confirming the software-generated measurements, and reviewing, confirming and approving draft reports based on their medical training. The device is intended to be used only by physicians, radiologist, hospitals and other medical institutions. Only T2 weighted DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are acceptable input. MSKai does not support DICOM images of patients that are pregnant, have post-operational complications, tumors, infections, or complex hardware.

Source page: https://510kreport.com/device/K240793
Methodology: https://510kreport.com/methodology