DXL CALSCAN— 510(k) K033550

Name: FDA 510(k) clearance K033550
Creator: U.S. Food and Drug Administration
Published: 2004-05-05

Substantially Equivalent

Demetech AB

FDA 510(k) clearance K033550 for DXL CALSCAN, Substantially Equivalent on 2004-05-05. Applicant: Demetech AB. Device class: 2.

Clearance details

Applicant: Demetech AB
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 2003-11-12
Decision date: 2004-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solna, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.