MFCD 1219, MFCD 1219 TS— 510(k) K052478

Substantially Equivalent

Barcoview

FDA 510(k) clearance K052478 for MFCD 1219, MFCD 1219 TS, Substantially Equivalent on 2005-09-28. Applicant: Barcoview.

Clearance details

Applicant: Barcoview
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2005-09-09
Decision date: 2005-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kortrijk, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.