# K132804: Acuson S1000 / S2000 / S3000

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro
- Decided: Oct 24, 2013 after 48 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 174 ancestors in all.
73 later devices descend from it; 2 cite it directly.
0 of 248 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130619: Acuson S1000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2013) Summary page 1.
- K123622: Acuson, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.
- K123001: Acuson X700 Diagnstic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.
- K130739: Acuson S2000 and S3000 Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2013) Summary page 1.
- K112596: Acuson S2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 1.
- K121138: Acuson S3000 Diagnostic Ultrasound System, Siemens Medical Solution (2012) Summary page 1.

## Most influential descendants
- 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
- K163635: ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems (2017), 48 descendants of its own

## Recalls of this device
- Jun 25, 2015 · Class II · Z-2321-2015: Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measureme
- Jun 25, 2015 · Class II · Z-2314-2015: Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
- Jun 3, 2014 · Class II · Z-1962-2014: There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

## Indications for use
The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. lntraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, trans-esophageal, transrectal, transvaginal. peripheral vessel. musculo-skeletal (conventional). musculo-skeletal (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 Echocardfiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging'. The Acuson Acunav Ultrasound 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/K132804
Methodology: https://510kreport.com/methodology