# K170144: StentBoost Live

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Stystems Nederland BV
- Decided: Jun 7, 2017 after 141 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: 1 generation back to K132305 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132305: Stentboost Rel. 4, Philips Medical Systems Nederland B.V. (2013) Summary page 4.

## Recalls of this device
- Feb 2, 2022 · Class II · Z-0874-2022: Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the sa

## Indications for use
StentBoost Live is intended to assist the physician during percutaneous coronary interventions. StentBoost Live provides real-time enhanced visualization of stents. StentBoost Live provides real-time enhanced visualization of stents in relation to coronary vessels. StentBoost Live assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of coronary stents. StentBoost Live is suitable for use with the entire adult human population. StentBoost Live is a software medical device and does not come in contact with a human subject.

Source page: https://510kreport.com/device/K170144
Methodology: https://510kreport.com/methodology