# K063085: Modification to Acuson Sequoia Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 14, 2006 after 35 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K935595 (1995). 22 ancestors in all.
838 later devices descend from it; 8 cite it directly.
2 of 861 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052410: Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.

## Most influential descendants
- K072786: Acuson S2000 Ultrasound System (2007), 800 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K091970: Aixplorer Ultrasound System (2009), 528 descendants of its own

## Recalls of this device
- Mar 21, 2009 · Not classified · Z-1961-2011: Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discom
- Jun 6, 2008 · Not classified · Z-2230-2008: The product assembly can cause a failure of the transducer which results in a double and/or overlapped image which may ultimately result in misleading or false information, inability to accurately dia
- Sep 25, 2007 · Not classified · Z-0661-2008: Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2)

## Indications for use
The Sequoia ultrasound imaging system 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 and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels, 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/K063085
Methodology: https://510kreport.com/methodology