# K132654: Acuson SC2000 Diagnostic Ultrasound System - Pathway: 510(k) (Traditional) - Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro - Decided: Sep 26, 2013 after 31 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: 18 generations back to K935595 (1995). 145 ancestors in all. 53 later devices descend from it; 3 cite it directly. 0 of 199 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K072365: Sequoia Plus Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1. - K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 3. - K102017: SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2010) Summary page 1. - K113179: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 1. - K123622: Acuson, Siemens Medical Solutions USA, Inc. (2012) Summary page 1. - K130754: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medi Cal Solutions, Inc. (2013) Summary page 1. - K111674: Acuson, Siemens Medical Solutions USA, Inc. (2011) Summary page 5. ## Most influential descendants - K142628: Acuson SC2000 Diagnostic Ultrasound System (2014), 50 descendants of its own - K162221: ACUSON SC2000 Diagnostic Ultrasound System (2016), 48 descendants of its own - K170315: Acuson SC2000 Diagnostic Ultrasound System (2017), 45 descendants of its own - K180067: ACUSON X800 Diagnostic Ultrasound System (2018), 28 descendants of its own - K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own ## Indications for use The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal lntraoperative. lntraoperative, 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 20 (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (GPO), Pulsed Wave (PR 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 transmits ultrasound energy from either a transthoracic or transesophageal approach in adult and pediatric patients: and from a transthoracic approach in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPO). Pulsed Wave (PVY) 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 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 (a), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWVD), 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. lntraoperatlve 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. Transcranlal Imaging Applications The system transmits ultrasound energy into the cranium of adult patients creating 20 (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. Source page: https://510kreport.com/device/K132654 Methodology: https://510kreport.com/methodology