# K021497: Cypress Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Acuson Corp.
- Decided: Jul 9, 2002 after 61 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934041 (1994). 7 ancestors in all.
898 later devices descend from it; 5 cite it directly.
2 of 906 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010950: Cypress System, Acuson Corp. (2001) Summary page 1.
- K982800: Ecton Lynx Ultrasound System, Ecton, Inc. (1998) Summary page 1.
- K991872: Lynx Ultrasound System, Ecton, Inc. (1999) Summary page 1.

## Most influential descendants
- K042055: Cypress Ultrasound System (2004), 827 descendants of its own
- 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

## Recalls of this device
- Feb 2, 2004 · Not classified · Z-0744-04: software problem - mode does not appear on screen
- Apr 1, 2003 · Not classified · Z-0975-03: software problem - loss of data

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K021497
Methodology: https://510kreport.com/methodology