K250762

Substantially Equivalent

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Applicant: Olympus Medical Systems Corporation
Product code: ITX
Advisory panel: Radiology
Date received: 2025-03-13
Decision date: 2025-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

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.