# K181966: SmartPerfusion

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederlands B.V.
- Decided: Aug 17, 2018 after 25 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
- Feb 20, 2023 · Class II · Z-1416-2023: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

## Indications for use
SmartPerfusion assists in the diagnosis of perfusion alterations of tissues based on digital subtraction angiography (DSA) and can be used for any location in the body where DSA is used.

Source page: https://510kreport.com/device/K181966
Methodology: https://510kreport.com/methodology