# K042055: Cypress Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 16, 2004 after 17 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: 4 generations back to K934041 (1994). 21 ancestors in all.
827 later devices descend from it; 2 cite it directly.
2 of 849 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021497: Cypress Ultrasound System, Acuson Corp. (2002) Summary page 1.
- K032114: Sequoia 8.0 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.

## Most influential descendants
- K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer (2005), 806 descendants of its own
- K063138: Modification to Acuson Antares Ultrasound System (2006), 802 descendants of its own
- K063803: Acuson Antares Diagnostic Ultrasound System (2007), 801 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

## Indications for use
Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: For intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - use in right heart only. Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K042055
Methodology: https://510kreport.com/methodology