# K131263: Xperguide

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jul 24, 2013 after 82 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 63 ancestors in all.
1 later device descends from it; 1 cites 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.
- K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP, GE Medical Systems SCS (2009) Summary page 2.

## Most influential descendants
- K201743: ClarifEye R1.0, ClarifEye Needle (2021), 0 descendants of its own

## Indications for use
XperGuide is an extension of XperCT, which assists in percutaneous interventions, such as biopsies, drainages, etc., by providing needle path planning and image guidance by superimposing live fluoroscopic images of the needle on a cross sectional image of the targeted anatomy. The XperGuide Ablation option assists with planning the position of multiple needles by visualizing the ablation coverage of the lesion.

Source page: https://510kreport.com/device/K131263
Methodology: https://510kreport.com/methodology