# K234030: Clear Guide SCENERGY

- Pathway: 510(k) (Special)
- Applicant: Clear Guide Medical
- Decided: Jan 17, 2024 after 28 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: 10 generations back to K911783 (1994). 54 ancestors in all.
No later device cites it as a predicate yet.
6 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201188: Clear Guide SCENERGY, Clear Guide Medical (2020) Summary page 4.

## Indications for use
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR. The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head 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, in patients of sufficient size (at least 25 kg).

Source page: https://510kreport.com/device/K234030
Methodology: https://510kreport.com/methodology