SIMULIX-MC CT EXTENSION— 510(k) K932848

Substantially Equivalent

Oldelft Corp. of America

FDA 510(k) clearance K932848 for SIMULIX-MC CT EXTENSION, Substantially Equivalent on 1994-03-22. Applicant: Oldelft Corp. of America.

Clearance details

Applicant: Oldelft Corp. of America
Product code: Code JAK
Advisory panel: Radiology
Date received: 1993-06-10
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.