# K041319: Sequoia Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 7, 2004 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: 4 generations back to K935595 (1995). 14 ancestors in all.
988 later devices descend from it; 3 cite it directly.
2 of 1,003 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032114: Sequoia 8.0 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K033196: Sonoline Antares with Clarify VE, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.

## Most influential descendants
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 descendants of its own
- K042770: Modification to Acuson CV70 Cardiovascular System (2004), 932 descendants of its own
- K050240: Modification to Acuson CV70 Cardiovascular System (2005), 927 descendants of its own
- K052894: Sonoline G60 S Ultrasound System (2005), 926 descendants of its own

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

Source page: https://510kreport.com/device/K041319
Methodology: https://510kreport.com/methodology