Acuson S328 Transducer
510(k) K874028
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874028 | Date21 Jun 1988 | 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- Withdrawn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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Acuson S328 Transducer is a phased array ultrasound probe designed for diagnostic imaging. It falls under the category of ultrasound transducers, which emit high-frequency sound waves to create images of internal body structures. This device is intended for use in radiology applications, enabling visualization of organs, tissues, and other anatomical features. Its design supports high-resolution imaging, particularly suited for abdominal, cardiac, and vascular assessments.
The Acuson S328 Transducer is supplied as a reusable component for ultrasound systems and is cleared for use in radiology settings. It was granted FDA 510(k) clearance under K-number K874028 in 1988, classified under the product code IYO. The device is intended for integration with ultrasound imaging equipment and does not require sterilization for each use, though standard cleaning protocols should be followed. No specific MRI safety information is provided in the regulatory data.
Other devices from Acuson Computed Sonography
Questions
AI-generated answers, 1 Oct 2026
What is the Acuson S328 Transducer used for?
The Acuson S328 Transducer is a phased array ultrasound probe designed specifically for diagnostic imaging in radiology. It emits high-frequency sound waves to produce detailed images of internal structures, making it ideal for assessing organs, tissues, and anatomical features. Its high-resolution capabilities are particularly suited for abdominal, cardiac, and vascular evaluations, enabling clinicians to visualize these areas with precision.
Is the Acuson S328 Transducer single-use or reusable?
The Acuson S328 Transducer is supplied as a reusable component for ultrasound systems. While it does not require sterilization for each use, it must adhere to standard cleaning protocols to maintain performance and hygiene. This design allows for repeated use across multiple patients, provided proper maintenance is followed.
What cleaning or maintenance procedures are recommended for the Acuson S328 Transducer?
The Acuson S328 Transducer is intended for reuse and should be cleaned according to standard protocols for ultrasound probes. While specific sterilization is not required for each use, thorough cleaning between patients is essential to prevent contamination and ensure optimal imaging quality. Follow manufacturer guidelines for cleaning agents and procedures to avoid damaging the probe.
Does the Acuson S328 Transducer have any special storage requirements?
The Acuson S328 Transducer does not have specialized storage requirements beyond general precautions for ultrasound probes. It should be stored in a clean, dry environment, protected from physical damage, extreme temperatures, and direct sunlight. Proper storage helps maintain the probe’s performance and longevity for repeated use.
What regulatory clearance does the Acuson S328 Transducer hold?
The Acuson S328 Transducer holds FDA 510(k) clearance under the K-number K874028, granted in 1988. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device and is classified under product code IYO. The device is intended for use in radiology settings as part of ultrasound imaging systems.