SPINEsim v1.0— 510(k) K261861

Name: FDA 510(k) clearance K261861
Creator: U.S. Food and Drug Administration
Published: 2026-09-15

Substantially Equivalent

Mdsim S.A.

FDA 510(k) clearance K261861 for SPINEsim v1.0, Substantially Equivalent on 2026-09-15. Applicant: Mdsim S.A.. Device class: 2.

Summary

SPINEsim v1.0 comes from Mdsim S.A. under product code LLZ (System, Image Processing, Radiological). The record doesn't describe the product beyond its name and code.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Mdsim filed from Esch-Sur-Alzette, Luxembourg. The decision came 103 calendar days after receipt (June 4 to September 15, 2026).

Clearance details

Applicant: Mdsim S.A.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-06-04
Decision date: 2026-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Esch-Sur-Alzette, LU

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K263648 — Vitrea Advanced Visualization, Version 7.162026-10-29
K261763 — MIM KineticID2026-10-26
K261531 — PV-iCurve Pro2026-10-21
K261788 — Eden PACS2026-10-21
K263048 — Syngo Carbon Space (VA4)2026-09-29

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.