# K152473: CAS-One IR

- Pathway: 510(k) (Traditional)
- Applicant: Cascination AG
- Decided: Jan 20, 2016 after 142 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: 3 generations back to K001284 (2000). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132108: MAXIO, Perfint Healthcare Pvt, Ltd. (2014) Summary page 6.
- K060903: IG4 Image Guided System, Veran Medical Technologies, Inc. (2006) Summary page 6.

## Most influential descendants
- K232022: CAS-One IR (2024), 1 descendant of its own
- K261225: CAS-One IR (2026), 0 descendants of its own
- K163643: Sirio H3 (2017), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K152473
Methodology: https://510kreport.com/methodology