CORONIS 3MP AND MDCG 3120-CB— 510(k) K061924

Name: FDA 510(k) clearance K061924
Creator: U.S. Food and Drug Administration
Published: 2006-09-05

Substantially Equivalent

Barcoview

FDA 510(k) clearance K061924 for CORONIS 3MP AND MDCG 3120-CB, Substantially Equivalent on 2006-09-05. Applicant: Barcoview. Device class: 2.

Clearance details

Applicant: Barcoview
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2006-07-07
Decision date: 2006-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kortrijk, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Barcoview

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K062621 — NIO 5MP-21 AND MDNG-5121 CB2007-03-19
K062905 — NIO FUSION 4MP; MDNC 41302006-12-29
K062131 — NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB2006-11-17
K061927 — CORONIS COLOR 3MP AND MDCC 3120-DL2006-09-05
K061928 — CORONIS COLOR 2MP AND MDCC 21212006-09-05

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.