K011224

Substantially Equivalent

HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY

Applicant: Advanced Technology Laboratories, Inc.
Product code: IYN
Advisory panel: Radiology
Date received: 2001-04-20
Decision date: 2001-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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.