# K223758: Epione

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Surgical Sas
- Decided: May 3, 2023 after 139 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001284 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211645: Epione, Quantum Surgical Sas (2022) Summary page 4.
- K132108: MAXIO, Perfint Healthcare Pvt, Ltd. (2014) Summary page 4.

## Recalls of this device
- May 23, 2025 · Class II · Z-1927-2025: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
- Aug 5, 2024 · Class II · Z-0037-2025: Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

## Indications for use
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position, during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

Source page: https://510kreport.com/device/K223758
Methodology: https://510kreport.com/methodology