# K261225: CAS-One IR

- Pathway: 510(k) (Traditional)
- Applicant: Cascination AG
- Decided: Sep 29, 2026 after 167 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: 5 generations back to K001284 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232022: CAS-One IR, Cascination AG (2024) Summary page 6.

## Indications for use
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures. In planning, the desired needle configuration and performance is defined relative to the target anatomy. In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored. In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data. CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures. CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.

Source page: https://510kreport.com/device/K261225
Methodology: https://510kreport.com/methodology