ACUSON L312 TRANSDUCER— 510(k) K853966

Substantially Equivalent

Acuson Computed Sonography

FDA 510(k) clearance K853966 for ACUSON L312 TRANSDUCER, Substantially Equivalent on 1986-02-20. Applicant: Acuson Computed Sonography.

Clearance details

Applicant: Acuson Computed Sonography
Product code: Code ITX
Advisory panel: Radiology
Date received: 1985-09-26
Decision date: 1986-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, 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.