# K052331: Acuson Cypress Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 10, 2005 after 76 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: 5 generations back to K934041 (1994). 22 ancestors in all.
167 later devices descend from it; 2 cite it directly.
2 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042055: Cypress Ultrasound System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K021497: Cypress Ultrasound System, Acuson Corp. (2002) Summary page 2.
- K010950: Cypress System, Acuson Corp. (2001) Summary page 1.
- K991872: Lynx Ultrasound System, Ecton, Inc. (1999) Summary page 1.
- K982800: Ecton Lynx Ultrasound System, Ecton, Inc. (1998) Summary page 2.
- K973767: Harmonic Imaging with Contrast, Acuson Corp. (1997) Summary page 1.

## Most influential descendants
- K063761: Acuson P10 Diagnostic Ultrasound System (2007), 135 descendants of its own
- K092756: GE Vscan Compact Diagnostic Ultrasound System (2009), 130 descendants of its own
- K090505: Speq Ultrasound System (2009), 107 descendants of its own
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 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:

Source page: https://510kreport.com/device/K052331
Methodology: https://510kreport.com/methodology