# K183575: ACUSON S3000, S2000 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthineers
- Decided: Mar 20, 2019 after 89 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: 24 generations back to K935595 (1995). 206 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172162: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems, Siemens Healthcare (2017) Summary page 5.
- K131164: Acuson, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.

## Most influential descendants
- K191922: ACUSON P200 Diagnostic Ultrasound System (2019), 23 descendants of its own
- K210743: ACUSON Redwood Diagnostic Ultrasound System (2021), 15 descendants of its own
- K211859: ACUSON Sequoia Diagnostic Ultrasound System (2021), 7 descendants of its own
- K221500: ACUSON Sequoia Diagnostic Ultrasound System (2022), 6 descendants of its own
- K202683: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic  Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON  NX3, NX3 Elite Diagnostic Ultrasound System (2020), 6 descendants of its own

## Indications for use
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), 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, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and neonatal cardiac} 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 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 AcuNav Catheter is 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 catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The Quantitative Ultrasound (QUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm by 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis. The Transducer Indications for Use on the attached pages.

Source page: https://510kreport.com/device/K183575
Methodology: https://510kreport.com/methodology