# K141846: Acuson X700 Ultrasound System, Acuson X600 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 7, 2014 after 29 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: 18 generations back to K935595 (1995). 175 ancestors in all.
41 later devices descend from it; 6 cite it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123001: Acuson X700 Diagnstic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 31.
- K112596: Acuson S2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 31.
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 31.
- K132804: Acuson S1000 / S2000 / S3000, Siemens Medical Solutions USA, Inc. Ultrasound Gro (2013) Summary page 31.

## Most influential descendants
- K152469: ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System (2015), 33 descendants of its own
- K161787: ACUSON NX2 Diagnostic Ultrasound Systems (2016), 30 descendants of its own
- K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own
- K180039: ACUSON P600 Diagnostic Ultrasound System (2018), 25 descendants of its own
- K191922: ACUSON P200 Diagnostic Ultrasound System (2019), 23 descendants of its own

## Indications for use
The Siemens ACUSON X700TM and X600 TM ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological 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 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 and Soundstar Ultrsound Catheter are 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/K141846
Methodology: https://510kreport.com/methodology