SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT— 510(k) K875187

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K875187 for SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT, Substantially Equivalent on 1988-12-12. Applicant: Shimadzu Corp..

Clearance details

Applicant: Shimadzu Corp.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1987-12-22
Decision date: 1988-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto City 604 Japan, JP

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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.