AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER— 510(k) K893833

Substantially Equivalent

Acoustic Imaging

FDA 510(k) clearance K893833 for AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER, Substantially Equivalent on 1989-09-11. Applicant: Acoustic Imaging.

Clearance details

Applicant: Acoustic Imaging
Product code: Code IYN
Advisory panel: Radiology
Date received: 1989-05-26
Decision date: 1989-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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.