ARTICOR planner— 510(k) K252195

Name: FDA 510(k) clearance K252195
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

Artiness S.R.L

FDA 510(k) clearance K252195 for ARTICOR planner, Substantially Equivalent on 2026-03-27. Applicant: Artiness S.R.L. Device class: 2.

Summary

Artiness S.R.L's ARTICOR planner is filed under LLZ, radiological image processing systems. The record doesn't describe the planner beyond its name and that code name.

Class II, 21 CFR 892.2050. It was a Traditional 510(k), and Radiology is both the classification panel and the review panel.

Artiness filed from Milan, Italy. The decision came 256 calendar days after FDA received it (July 14, 2025 to March 27, 2026).

Clearance details

Applicant: Artiness S.R.L
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-07-14
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

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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.