ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.— 510(k) K874363

Substantially Equivalent

Acuson Computed Sonography

FDA 510(k) clearance K874363 for ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI., Substantially Equivalent on 1988-05-02. Applicant: Acuson Computed Sonography.

Clearance details

Applicant: Acuson Computed Sonography
Product code: Code IYO
Advisory panel: Radiology
Date received: 1987-10-23
Decision date: 1988-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.