EUB-410 DIAGNOSTIC ULTRASOUND DEVICE— 510(k) K871004

Substantially Equivalent

Hitachi Medical Corp. of America

FDA 510(k) clearance K871004 for EUB-410 DIAGNOSTIC ULTRASOUND DEVICE, Substantially Equivalent on 1987-12-11. Applicant: Hitachi Medical Corp. of America.

Clearance details

Applicant: Hitachi Medical Corp. of America
Product code: Code IYO
Advisory panel: Radiology
Date received: 1987-03-12
Decision date: 1987-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.