Acuson S228 Transducer for Transcranial Doppler

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K890055 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the ACUSON S228 Transducer used for?

  The ACUSON S228 Transducer is designed for use in transcranial Doppler examinations, which assess blood flow velocity in the cerebral arteries to evaluate conditions such as vasospasm, stroke risk, or intracranial stenosis. It is intended for diagnostic ultrasound applications as specified in its FDA 510(k) clearance.

• Who manufactures the ACUSON S228 Transducer and where is it made?

  The ACUSON S228 Transducer is manufactured by Acuson Corp., located at 1220 Charleston Rd., Mountain View, CA 94039, United States. The manufacturer and address are specified in the FDA 510(k) submission documentation.

• What regulatory pathway was used for the ACUSON S228 Transducer?

  The ACUSON S228 Transducer received FDA 510(k) clearance (K890055) on May 16, 1989, through a traditional review process, where it was determined to be substantially equivalent to a legally marketed predicate device. This is the regulatory route under which it was authorized for market.