# K123001: Acuson X700 Diagnstic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 26, 2012 after 29 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 159 ancestors in all.
74 later devices descend from it; 4 cite it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.
- K112596: Acuson S2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 1.
- K113663: Sonixtablet Ultrasound Scanner, Ultrasonix Medical Corporation (2012) Summary page 1.
- K102997: Sonixtablet Ultrasound Scanner, Ultrasonix Medical Corporation (2010) Summary page 1.

## Most influential descendants
- K132804: Acuson S1000 / S2000 / S3000 (2013), 73 descendants of its own
- K140959: Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems (2014), 60 descendants of its own
- K142876: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems (2014), 58 descendants of its own
- K152369: ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System (2015), 54 descendants of its own
- K162243: ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System (2016), 49 descendants of its own

## Recalls of this device
- Sep 5, 2015 · Class II · Z-1572-2016: Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system 
- Apr 2, 2014 · Class II · Z-1504-2014: When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current pat

## Indications for use
The Siemens ACUSON X 7 00 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 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/K123001
Methodology: https://510kreport.com/methodology