DIAGNOSTIC ULTRASOUND/URO-GYN UD 511— 510(k) K911166

Substantially Equivalent

Diagnostic Ultrasound Corp.

FDA 510(k) clearance K911166 for DIAGNOSTIC ULTRASOUND/URO-GYN UD 511, Substantially Equivalent on 1991-08-15. Applicant: Diagnostic Ultrasound Corp..

Clearance details

Applicant: Diagnostic Ultrasound Corp.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1991-03-15
Decision date: 1991-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.