Mimics Cardiac Planner
FDA 510(k) K233217 · Materialise NV
510(k) numberK233217
Submission
- Device name
- Mimics Cardiac Planner
- Applicant
- Materialise NV
Leuven, BE - Received
- September 28, 2023
- Decision date
- February 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mimics Cardiac Planner cleared by the FDA?
Mimics Cardiac Planner (K233217) received a 510(k) decision of Substantially Equivalent on February 12, 2024, 137 days after the submission was received.
What is the product code of K233217?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.