# K243378: Rapid MLS

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: May 28, 2025 after 210 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: 9 generations back to K945512 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223396: Rapid RV/LV, Ischemaview, Inc. (2023) Summary page 5.

## Indications for use
The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. The Rapid MLS device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases.

Source page: https://510kreport.com/device/K243378
Methodology: https://510kreport.com/methodology