Cleared Traditional

Mimics Thoracic Planner

K251964 · Materialise NV · Radiology
Mar 2026
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K251964 is an FDA 510(k) clearance for the Mimics Thoracic Planner, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on March 12, 2026, 259 days after receiving the submission on June 26, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251964 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2025
Decision Date March 12, 2026
Days to Decision 259 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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