KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM— 510(k) K862686

Substantially Equivalent

Kontron Instruments, Inc.

FDA 510(k) clearance K862686 for KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM, Substantially Equivalent on 1987-02-27. Applicant: Kontron Instruments, Inc..

Clearance details

Applicant: Kontron Instruments, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1986-07-15
Decision date: 1987-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Everett, MA, 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.