ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
by Siemens Medi Cal Solutions, Inc.
510(k) K162243
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162243 | Date6 Sep 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Acuson S1000 / S2000 / S3000 Diagnostic Ultrasound System is a diagnostic imaging device classified as an ultrasound machine. It generates real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes. These systems are designed for a range of applications, including obstetrics, cardiology, abdominal, and vascular imaging. The S3000 model additionally supports advanced imaging techniques such as elastography and contrast-enhanced ultrasound.
The system is supplied as a reusable, non-sterile medical device intended for use in clinical settings such as hospitals, diagnostic centers, and outpatient facilities. It operates within MRI-safe parameters as defined by its electromagnetic and acoustic emissions. The systems are authorized for use in the United States under FDA 510(k) clearance (K162243) and are distributed by Siemens Medi Cal Solutions, Inc. Proper maintenance and calibration are required to ensure accurate imaging performance, and storage should follow manufacturer guidelines to preserve functionality.
Other devices from Siemens Medi Cal Solutions, Inc.
Questions
AI-generated answers, 1 Oct 2026
What advanced imaging techniques does the Acuson S3000 support that the S1000 and S2000 do not?
The Acuson S3000 model uniquely supports elastography and contrast-enhanced ultrasound, which allow clinicians to evaluate tissue stiffness and blood flow dynamics respectively. Elastography helps differentiate between benign and malignant tissues by measuring tissue hardness, while contrast-enhanced ultrasound improves visualization of vascular structures and perfusion. These features are particularly useful in oncology, liver assessment, and vascular studies.
Is the Acuson S1000/S2000/S3000 system reusable or single-use?
The Acuson S1000/S2000/S3000 systems are designed as reusable, non-sterile medical devices. They are intended for repeated use in clinical settings like hospitals and diagnostic centers, provided they undergo proper maintenance, calibration, and cleaning as specified by the manufacturer. Reusability ensures cost-effectiveness and consistent performance over time, but requires adherence to infection control protocols.
Can this ultrasound system be used safely in an MRI environment?
Yes, the Acuson S1000/S2000/S3000 systems are designed to operate within MRI-safe parameters based on their electromagnetic and acoustic emissions. This means they can be used in proximity to MRI machines without compromising MRI safety standards. However, specific placement and usage guidelines should be followed to avoid interference or safety risks, as outlined in the manufacturer’s instructions.
What clinical applications are the S1000/S2000/S3000 systems primarily used for?
These systems are versatile and widely used for a variety of diagnostic applications, including obstetrics (fetal imaging), cardiology (heart structure and function), abdominal imaging (liver, kidneys, pancreas), and vascular studies (blood flow assessment). The S3000’s additional elastography and contrast-enhanced ultrasound capabilities expand its utility for soft tissue characterization and perfusion studies, such as in oncology or liver disease evaluation.
What maintenance and storage requirements are necessary to ensure optimal performance?
To maintain accurate imaging performance, the Acuson S1000/S2000/S3000 systems require regular maintenance and calibration as specified by Siemens. Storage should follow manufacturer guidelines to preserve functionality, including protection from extreme temperatures, humidity, and physical damage. Proper cleaning and disinfection protocols must also be followed after each use to prevent contamination and ensure longevity of the device.