INTRA-OPERATIVE ULTRASOUND TRANSDUCER— 510(k) K140854

Name: FDA 510(k) clearance K140854
Creator: U.S. Food and Drug Administration
Published: 2014-06-11

Substantially Equivalent

Hitachi Aloka Medical, Ltd.

FDA 510(k) clearance K140854 for INTRA-OPERATIVE ULTRASOUND TRANSDUCER, Substantially Equivalent on 2014-06-11. Applicant: Hitachi Aloka Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Hitachi Aloka Medical, Ltd.
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2014-04-03
Decision date: 2014-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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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.