INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM— 510(k) K911114

Substantially Equivalent

Interson Corp.

FDA 510(k) clearance K911114 for INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM, Substantially Equivalent on 1991-11-19. Applicant: Interson Corp..

Clearance details

Applicant: Interson Corp.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1991-03-07
Decision date: 1991-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.