# K223804: PercuNav Image Fusion and Interventional Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, LLC
- Decided: Jan 18, 2023 after 30 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K911783 (1994). 53 ancestors in all.
No later device cites it as a predicate yet.
6 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201053: PercuNav Image Fusion and Interventional Navigation, Philips Ultrasound, Inc. (2020) Summary page 4.

## Indications for use
The PercuNav Image Fusion and Interventional Navigation System is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PercuNav Image Fusion and Interventional Navigation System is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting. The PercuNav Image Fusion and Interventional Navigation System is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another. The PercuNav Image Fusion and Interventional Navigation System is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav Image Fusion and Interventional Navigation System adjunctively include, but are not limited to, the following: • Image fusion for diagnostic clinical examinations and procedures • Soft tissue biopsies • Soft tissue ablation • Bone ablation • Bone biopsies • Nerve blocks and pain management • Drainage placements

Source page: https://510kreport.com/device/K223804
Methodology: https://510kreport.com/methodology