# K160455: AneurysmFlow

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 25, 2016 after 189 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 63 ancestors in all.
No later device cites it as a predicate yet.
1 of 64 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132147: 2D Perfusion, Philips Medical Systems Nederland B.V. (2013) Summary page 4.

## Recalls of this device
- Mar 19, 2026 · Class II · Z-1805-2026: Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic in

## Indications for use
AneurysmFlow assists during endovascular procedures for treating of saccular cerebral aneurysms, by: • Visualization of blood flow patterns in the aneurysm and parent vessel, based on digital subtraction angiography. • Quantification of the blood flow in the aneurysm parent vessel, based on digital subtraction angiography and 3D rotational angiography. • Comparison of blood flow, both visual and quantified between two acquisitions.

Source page: https://510kreport.com/device/K160455
Methodology: https://510kreport.com/methodology