# K163478: AcuNav Volume ICE Catheter

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 9, 2017 after 59 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: 1 generation back to K081808 (2008). 1 ancestor in all.
24 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081808: Acunav V Ultrasound Catheter, Siemens Medical Solutions USA, Inc. (2008) Summary page 5.

## Most influential descendants
- K173618: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter (2017), 23 descendants of its own
- K181098: ACUSON SC2000 Diagnostic Ultrasound System (2018), 19 descendants of its own
- K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (2019), 9 descendants of its own
- K200585: Acuson SC2000 Diagnostic Ultrasound System (2020), 8 descendants of its own
- K201972: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (2020), 7 descendants of its own

## Indications for use
The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.

Source page: https://510kreport.com/device/K163478
Methodology: https://510kreport.com/methodology