INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.— 510(k) K900555

Substantially Equivalent

Interson Corp.

FDA 510(k) clearance K900555 for INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA., Substantially Equivalent on 1990-05-02. Applicant: Interson Corp..

Clearance details

Applicant: Interson Corp.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1990-02-06
Decision date: 1990-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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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.