ETIAM PACS COMPONENTS— 510(k) K131392

Name: FDA 510(k) clearance K131392
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Substantially Equivalent

Etiam S.A.S.U.

FDA 510(k) clearance K131392 for ETIAM PACS COMPONENTS, Substantially Equivalent on 2013-05-29. Applicant: Etiam S.A.S.U.. Device class: 2.

Clearance details

Applicant: Etiam S.A.S.U.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2013-05-14
Decision date: 2013-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rennes, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K262060 — 3D-RD-S2026-09-04
K261500 — KBA3D (v2.4.0)2026-08-17
K262449 — AdvaView2026-08-14
K261916 — NeuroQuant PET2026-08-12
K260936 — RadioViewAI2026-07-31

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.