# K153004: Clear Guide SCENERGY

- Pathway: 510(k) (Traditional)
- Applicant: Clear Guide Medical
- Decided: Feb 12, 2016 after 122 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.
4 later devices descend from it; 1 cites it directly.
6 of 56 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
- K171677: Clear Guide SCENERGY (2017), 3 descendants of its own
- K201188: Clear Guide SCENERGY (2020), 1 descendant of its own
- K234030: Clear Guide SCENERGY (2024), 0 descendants of its own
- K201898: Clear Guide SCENERGY (2020), 0 descendants of its own

## Indications for use
The Clear Guide Scenergy is a stereotaxic accessory for the fusion of images from Computed Tomography (CT) and Ultrasound (US) modalities. The Clear Guide Scenergy utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide Scenergy might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.

Source page: https://510kreport.com/device/K153004
Methodology: https://510kreport.com/methodology