# K032114: Sequoia 8.0 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 21, 2003 after 12 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: 3 generations back to K935595 (1995). 12 ancestors in all.
1,003 later devices descend from it; 3 cite it directly.
2 of 1,016 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 2.

## Most influential descendants
- K041319: Sequoia Diagnostic Ultrasound System (2004), 988 descendants of its own
- 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

## Indications for use
The Sequoia diagnostic ultrasound system is intended for the following: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and analysis packages that provide information that is used for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K032114
Methodology: https://510kreport.com/methodology