# K230534: BriefCase-Quantification

- Pathway: 510(k) (Traditional)
- Applicant: Aidoc Medical, Ltd.
- Decided: Nov 8, 2023 after 254 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.
3 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221100: Viz RV/LV, Viz. Ai, Inc. (2022) Summary page 4.

## Most influential descendants
- K241112: BriefCase-Quantification (2024), 1 descendant of its own
- K243779: Bunkerhill Abdominal Aortic Quantification (AAQ) (2025), 0 descendants of its own
- K242203: BriefCase-Quantification (2024), 0 descendants of its own

## Indications for use
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older. The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter measurement of cases that include the abdominal aorta (M-AbdAo). BriefCase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas. 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/K230534
Methodology: https://510kreport.com/methodology