Cleared Traditional

Mimics Cardiac Planner

K233217 · Materialise NV · Radiology
Feb 2024
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K233217 is an FDA 510(k) clearance for the Mimics Cardiac 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 February 12, 2024, 137 days after receiving the submission on September 28, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K233217 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date February 12, 2024
Days to Decision 137 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