# K242203: BriefCase-Quantification

- Pathway: 510(k) (Traditional)
- Applicant: Aidoc Medical, Ltd.
- Decided: Nov 22, 2024 after 119 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: 11 generations back to K945512 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241112: BriefCase-Quantification, Aidoc Medical, Ltd. (2024) Summary page 5.

## Indications for use
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older. BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas. The device provides the following assessments: * Aortic measurements at 10 anatomical landmarks; * Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta. 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. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K242203
Methodology: https://510kreport.com/methodology