EUP-C321 5.0MHZ CONVEX TYPE PROBE— 510(k) K890532

Substantially Equivalent

Hitachi Medical Corp. of America

FDA 510(k) clearance K890532 for EUP-C321 5.0MHZ CONVEX TYPE PROBE, Substantially Equivalent on 1990-04-13. Applicant: Hitachi Medical Corp. of America.

Clearance details

Applicant: Hitachi Medical Corp. of America
Product code: Code ITX
Advisory panel: Radiology
Date received: 1989-02-02
Decision date: 1990-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.