# K051139: Acuson Sequoia Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 13, 2005 after 9 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 K935595 (1995). 20 ancestors in all.
979 later devices descend from it; 5 cite it directly.
2 of 1,000 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041319: Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K022303: Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound Transducer, Philips Ultrasound, Inc. (2002) Summary page 1.
- K041552: GE Vivid 7 BT04, General Electric Co. (2004) Summary page 2.

## Most influential descendants
- K052410: Acuson Sequoia Ultrasound System (2005), 972 descendants of its own
- K063085: Modification to Acuson Sequoia Ultrasound System (2006), 838 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

## Indications for use
The Sequoia platform is intended for use in the following applications: 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-sceletal (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 for analysis packages that provide information that is used for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K051139
Methodology: https://510kreport.com/methodology