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FDA 510(k)

Mimics Thoracic Planner

K-Number: K251964 · 2026-03-12

ApplicantMaterialise NV
Decision Date2026-03-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mimics Thoracic Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K251964. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mimics Thoracic Planner?

Mimics Thoracic Planner is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Materialise NV. The 510(k) number is K251964.

When did Mimics Thoracic Planner receive FDA 510(k) clearance?

Mimics Thoracic Planner received FDA 510(k) clearance on 2026-03-12, under 510(k) number K251964.

Who is the listed applicant for Mimics Thoracic Planner?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mimics Thoracic Planner?

The FDA product code for Mimics Thoracic Planner is LLZ.

Other records listing Materialise NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryK242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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