# K082142: Acuson S2000 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decided: Nov 13, 2008 after 106 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acuson Antares Ultrasound System: named in the summary without a submission number

## Recalls of this device
- Mar 15, 2011 · Not classified · Z-2051-2011: The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.
- Aug 17, 2010 · Not classified · Z-1837-2011: There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient 
- Oct 2, 2009 · Not classified · Z-1007-2011: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Oct 2, 2009 · Not classified · Z-1005-2011: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Oct 2, 2009 · Not classified · Z-1006-2011: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Aug 28, 2009 · Not classified · Z-1392-2011: If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Nor
- Apr 7, 2009 · Not classified · Z-1884-2011: Device function failure--When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into t
- Jan 14, 2009 · Not classified · Z-1900-2011: The product has a software problem in which previous patient measurement data gets associated with another patient's image.

## Indications for use
The S2000TM ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, 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, intraoperative neurological, 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 that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K082142
Methodology: https://510kreport.com/methodology