# K131164: Acuson

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 24, 2013 after 244 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: 14 generations back to K935595 (1995). 80 ancestors in all.
124 later devices descend from it; 2 cite it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111674: Acuson, Siemens Medical Solutions USA, Inc. (2011) Summary page 1.
- K122825: Acuson, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.
- K112255: Aixplorer, Supersonic Imagine (2012) Summary page 1.
- K121329: Aixplorer, Supersonic Imagine (2012) Summary page 1.

## Most influential descendants
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own
- K153529: WS80A Diagnostic Ultrasound System (2016), 89 descendants of its own
- K153408: HM70A Diagnostic Ultrasound System (2015), 65 descendants of its own
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own

## Indications for use
The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. lntraoperative. Pediatric. Small Parts. Transcranial. OSIGYN. 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. intratoperative neurological, pediatric small organ, neonatal cephalic. adult cephalic. cardiac. trans-esophageal. transrectal. transvaginal. peripheral vessel. musculo-skeletal (conventional). niusculo-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 Neath Package (AHP) software provides the physician with the capabiity 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 withi 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. Endowsed by the Society for Vascular Imaging'. The Acuson Acunav Ultrasound Catheter is intended for innr-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/K131164
Methodology: https://510kreport.com/methodology