# K201352: 3D Auto LAA

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Aug 17, 2020 after 88 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: 17 generations back to K935595 (1995). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191647: QLAB Advanced Quantification Software, Philips Health Care (2019) Summary page 6.

## Indications for use
The 3D Auto LAA is a software application designed to view and quantify 3D image data acquired by Philips Ultrasound Systems for use in measuring the area, circumference, and diameter of a Left Atrial Appendage (LAA) orifice.

Source page: https://510kreport.com/device/K201352
Methodology: https://510kreport.com/methodology