# K132087: Percunav System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Jul 24, 2013 after 19 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: 6 generations back to K911783 (1994). 50 ancestors in all.
9 later devices descend from it; 2 cite it directly.
6 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121498: Percunav, Philips Health Care (2012) Summary page 2.

## Most influential descendants
- K153004: Clear Guide SCENERGY (2016), 4 descendants of its own
- K171677: Clear Guide SCENERGY (2017), 3 descendants of its own
- K170716: PercuNav Image Fusion and Interventional Navigation (2017), 3 descendants of its own
- K201188: Clear Guide SCENERGY (2020), 1 descendant of its own
- K201053: PercuNav Image Fusion and Interventional Navigation (2020), 1 descendant of its own

## Indications for use
PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Rotational Fluoroscopy, Endoscopy and other imaging systems. CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, such as CT with MR, MR with ultrasound, etc. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle, guidewire 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 taking into account patient movement. This is intended for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. The device 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: * Image fusion for diagnostic clinical examinations and procedures * Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, etc.) * Soft tissue ablation (liver, kidney, breast, pancreas lung, etc.) * Bone ablations * Bone biopsies * Nerve Blocks & Pain Management * Drainage placements * Hydrodissections * Bladder Stimulation * Fiducial placements * Tumor resections * Sinus procedures * Intranasal procedures * Transphenoidal procedures

Source page: https://510kreport.com/device/K132087
Methodology: https://510kreport.com/methodology