# K111674: Acuson

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 30, 2011 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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: 12 generations back to K935595 (1995). 63 ancestors in all.
223 later devices descend from it; 6 cite it directly.
0 of 287 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063803: Acuson Antares Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 8.
- K093812: Acuson S2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2010) Summary page 1.
- K090334: Acuson S2000 Diagnostic Ultrasound System, Siemens Medi Cal Solutions, Inc. (2009) Summary page 1.
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K081148: Siemens Acuson 2000 Ultrasound System with Abvs Transducer, Siemens Medical Solutions USA, Inc., Ultrasound DI (2008) Summary page 1.
- K063085: Modification to Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Most influential descendants
- K121138: Acuson S3000 Diagnostic Ultrasound System (2012), 198 descendants of its own
- K130739: Acuson S2000 and S3000 Diagnostic Ultrasound Systems (2013), 177 descendants of its own
- K131164: Acuson (2013), 124 descendants of its own
- K130881: Acuson S2000 and S3000 (2013), 116 descendants of its own
- K133329: Ugeo WS80A Diagnostic Ultrasound System (2013), 102 descendants of its own

## Recalls of this device
- Apr 25, 2012 · Not classified · Z-1616-2012: When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
- Apr 23, 2012 · Not classified · Z-1684-2012: When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
- Apr 23, 2012 · Not classified · Z-1685-2012: When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.

## Indications for use
The S2000OTM ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraolperative, Pediatric, Small Parts, Trariscranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement, Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Source page: https://510kreport.com/device/K111674
Methodology: https://510kreport.com/methodology