# K242607: ScanDiags Ortho L-Spine MR-Q

- Pathway: 510(k) (Traditional)
- Applicant: Scandiags AG
- Decided: Feb 21, 2025 after 171 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.

## Indications for use
ScanDiags Ortho L-Spine MR-Q software is an image-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, and documenting area and distance measurements of relevant anatomical structures (vertebral body, intervertebral disc, neuroforamina, thecal sac) of the lumbar spine: Feature Segmentation; Feature measurement; and Export of measurement results to a PDF report containing measurement results and overlay images for user's review, revise and approval. ScanDiags Ortho L-Spine MR-Q software does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for reviewing and verifying the software-generated measurements and approving draft report content using their medical judgment and discretion. The device is intended to be used only by hospitals and other medical institutions. Only DICOM images of MRI acquired from lumbar spine exams of patients aged 22 and above are considered to be valid input. ScanDiags Ortho L-Spine MR-Q software does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, have post-operational complications or infections.

Source page: https://510kreport.com/device/K242607
Methodology: https://510kreport.com/methodology