# K142395: SC2000 and ACUSON X300 Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 9, 2014 after 13 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132654: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. Ultrasound Gro (2013) Summary page 37.
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 52.
- K123001: Acuson X700 Diagnstic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 52.
- K141846: Acuson X700 Ultrasound System, Acuson X600 Ultrasound System, Siemens Medical Solutions USA, Inc. (2014) Summary page 52.
- K140318: Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound Catheter, Biosense Webster (2014) Summary page 52.
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 47.

## Indications for use
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms, legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. Intraoperative Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures. Transcranial Imaging Applications The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. . 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/K142395
Methodology: https://510kreport.com/methodology