510(k) K222365— Leltek Ultrasound Imaging System (Model: LU700 Series)

Substantially Equivalent

Leltek, Inc.

Clearance details

Applicant: Leltek, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2022-08-04
Decision date: 2022-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.