# K250955: XC11 ICE System, USA

- Pathway: 510(k) (Traditional)
- Applicant: Yorlabs, Inc.
- Decided: Oct 22, 2025 after 205 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K935595 (1995). 214 ancestors in all.
No later device cites it as a predicate yet.
0 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163396: ACUSON P500 Ultrasound System, Siemens Medical Solutions USA, Inc. (2017) Summary page 5.
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 5.

## Indications for use
The XC11 ICE Box Ultrasound System is intended for intra-cardiac and intra-luminal ultrasound imaging when operated with the XC11 ICE Catheter and XC11 ICE System Handle The XC11 ICE Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The XC11 ICE Catheter is for use with Yorlabs XC11 ICE System Handle only.

Source page: https://510kreport.com/device/K250955
Methodology: https://510kreport.com/methodology