LUMYS (V1)— 510(k) K243069

Name: FDA 510(k) clearance K243069
Creator: U.S. Food and Drug Administration
Published: 2025-05-02

Substantially Equivalent

Intradys

FDA 510(k) clearance K243069 for LUMYS (V1), Substantially Equivalent on 2025-05-02. Applicant: Intradys. Device class: 2.

Clearance details

Applicant: Intradys
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-09-27
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brest, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

K261500 — KBA3D (v2.4.0)2026-08-17
K262449 — AdvaView2026-08-14
K261916 — NeuroQuant PET2026-08-12
K260936 — RadioViewAI2026-07-31
K260588 — Cleerly LABS2026-07-29

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.