# K200603: AAA Model

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Sep 20, 2020 after 195 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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 K935595 (1995). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200974: QLAB Advanced Quantification Software, Philips Health Care (2020). Cleared while this submission was under review Summary page 6.

## Indications for use
The AAA Model is a software application designed to view and quantify 3D image data acquired by Philips diagnostic ultrasound systems for use in measuring the anterior-posterior diameter of abdominal aortic aneurysms. Optionally, lateral diameter, maximum diameter, and partial volume of an abdominal aortic aneurysm can also be provided. It is intended to be used by trained and qualified healthcare professionals in clinics, hospitals, and clinical point-of-care facilities.

Source page: https://510kreport.com/device/K200603
Methodology: https://510kreport.com/methodology