# K232083: BriefCase-Quantification

- Pathway: 510(k) (Traditional)
- Applicant: Aidoc Medical, Ltd.
- Decided: Nov 13, 2023 after 123 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: 5 generations back to K061855 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211222: qER-Quant, Qure.Ai Technologies (2021) Summary page 4.

## Indications for use
BriefCase-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older. The device is intended to assist appropriately trained medical specialists by providing the user with an automated current manual process of measuring midline shift. The device provides midline shift measurement from NCCT images acquired at a single time point, and can additionally provide an output with comparative analysis of two or more images that were acquired in the same individual at multiple time points. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K232083
Methodology: https://510kreport.com/methodology