# K022567: Sequoia Signature II Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Acuson Corp.
- Decided: Aug 13, 2002 after 11 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: 2 generations back to K935595 (1995). 11 ancestors in all.
1,069 later devices descend from it; 10 cite it directly.
2 of 1,081 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935595: Acuson Model 3001, Acuson Corp. (1995) Summary page 2.
- K973767: Harmonic Imaging with Contrast, Acuson Corp. (1997) Summary page 2.
- K992580: Fetal Assessment Cap, Acuson Corp. (1999) Summary page 2.
- K992631: Acunav Diagnostic Ultrasound Catheter, Acuson Corp. (1999) Summary page 2.
- K002807: 3D Organ Assessment W/ Magnetic Position Sensing, Acuson Corp. (2000) Summary page 2.
- K991805: Aspen Ultrasound with Freestyle Imaging Option, Acuson Corp. (1999) Summary page 2.
- K002470: M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A Transducer, Agilent Technologies, Inc. (2000) Summary page 2.

## Most influential descendants
- K032114: Sequoia 8.0 Diagnostic Ultrasound System (2003), 1,003 descendants of its own
- 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
- K032111: Acuson CV70 Cardiovascular System (2003), 955 descendants of its own

## Indications for use
The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), NeonataVAdult Cephalic, Cardiac (adult and pediatric), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (Superficial and Conventional) applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The AcuNav diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

Source page: https://510kreport.com/device/K022567
Methodology: https://510kreport.com/methodology