# K173618: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 19, 2017 after 27 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081808 (2008). 2 ancestors in all.
23 later devices descend from it; 2 cite 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)
- K163478: AcuNav Volume ICE Catheter, Siemens Medical Solutions USA, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K212333: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 (2022), 6 descendants of its own

## Recalls of this device
- May 22, 2020 · Class II · Z-0090-2021: Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.

## Indications for use
The catheter is intended for intracardiac 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.

Source page: https://510kreport.com/device/K173618
Methodology: https://510kreport.com/methodology