# K132147: 2D Perfusion

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Dec 16, 2013 after 158 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: 9 generations back to K801623 (1980). 62 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 65 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033737: Allura Xper FD20, Philips Medical Systems North America, Inc. (2003) Summary page 1.
- K102005: Allura Xper or Table Series, Philips Medical Systems North America, Inc. (2010) Summary page 1.
- K110834: AW Volumeshare 5 with Angioviz Option, GE Healthcare (2011) Summary page 2.

## Most influential descendants
- K181966: SmartPerfusion (2018), 0 descendants of its own
- K160455: AneurysmFlow (2016), 0 descendants of its own

## Recalls of this device
- Feb 20, 2023 · Class II · Z-1417-2023: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

## Indications for use
2D Perfusion assists in the diagnosis of perfusion alterations of tissues. based on digital subtraction angiography (DSA), by providing color coded images generated from the DSA series.

Source page: https://510kreport.com/device/K132147
Methodology: https://510kreport.com/methodology