ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM— 510(k) K900805

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K900805 for ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM, Substantially Equivalent on 1990-08-23. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code IYO
Advisory panel: Radiology
Date received: 1990-02-21
Decision date: 1990-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.