# K170716: PercuNav Image Fusion and Interventional Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Apr 21, 2017 after 43 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: 7 generations back to K911783 (1994). 51 ancestors in all.
3 later devices descend from it; 2 cite it directly.
6 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132087: Percunav System, Philips Health Care (2013) Summary page 4.

## Most influential descendants
- K201053: PercuNav Image Fusion and Interventional Navigation (2020), 1 descendant of its own
- K223804: PercuNav Image Fusion and Interventional Navigation System (2023), 0 descendants of its own
- K192914: Stimuplex Onvision System (2020), 0 descendants of its own

## Indications for use
The PercuNav system is a stereotaxic accessory for computed tomography (CT), 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 system is intended for treatment planning and guidance for clinical, interventional, or diagnostic procedures. The PercuNav system also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The PercuNav system is intended to be used in interventional and diagnostic procedures in a clinical setting. The PercuNav system is also intended for use in clinical interventions to determine the proximity of one device relative to another. Example procedures include, but are not limited to, the following: • Image fusion for diagnostic clinical examinations and procedures • Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.) • Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on) • Bone ablations • Bone biopsies • Nerve blocks and pain management • Drainage placements • Tumor resections

Source page: https://510kreport.com/device/K170716
Methodology: https://510kreport.com/methodology