# K241108: RemedyLogic AI MRI Lumbar Spine Reader

- Pathway: 510(k) (Traditional)
- Applicant: Remedy Logic, Inc.
- Decided: Oct 30, 2024 after 191 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
RemedyLogic AI MRI Lumbar Spine Reader (“RAI”) is an image post-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, measuring and documenting measurements: • Feature segmentation; • Feature measurement; and • Exportation of measurement results in a DICOM Structured Report and a downloadable .docx file for users to review and to use full or partial list of software-generated measurements to prepare their own radiology report. RAI does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and measure features in lumbar MR images and compile their own reports. The user is responsible for reviewing, verifying, and correcting, if necessary, the software-generated segmentations and measurements, leveraging useful software output and using their medical judgment and discretion to make diagnostic or treatment decisions. The device is intended to be used only by radiologists, neuro- and spine-surgeons in hospitals and other medical institutions. Only T2 MRI images in DICOM format, acquired from lumbar spine exams of patients aged 18 and older, are considered to be valid input. RAI does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, scoliosis, tumors, infections, and/or fractures.

Source page: https://510kreport.com/device/K241108
Methodology: https://510kreport.com/methodology