GENERAL ULTRASOUND EXAM. TABLE— 510(k) K802254

Substantially Equivalent

Engineering Dynamics Corp.

FDA 510(k) clearance K802254 for GENERAL ULTRASOUND EXAM. TABLE, Substantially Equivalent on 1980-11-26. Applicant: Engineering Dynamics Corp..

Clearance details

Applicant: Engineering Dynamics Corp.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1980-09-16
Decision date: 1980-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.