# K052410: Acuson Sequoia Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 22, 2005 after 20 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935595 (1995). 21 ancestors in all.
972 later devices descend from it; 7 cite it directly.
2 of 994 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051139: Acuson Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.

## Most influential descendants
- K063085: Modification to Acuson Sequoia Ultrasound System (2006), 838 descendants of its own
- K072786: Acuson S2000 Ultrasound System (2007), 800 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Indications for use
Ultrasound imaging or fluid flow analysis of the human body as follows: The AcuNavTM Ultrasound 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. The AcuNaVTM Ultrasound 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.

Source page: https://510kreport.com/device/K052410
Methodology: https://510kreport.com/methodology