FDA 510(k)

MirrorMe3D Modeling System

K-Number: K212981 · 2022-04-22

Decision Date2022-04-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MirrorMe3D Modeling System is the device name listed in this FDA 510(k) record. The listed applicant is Mirrorme3D, LLC. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K212981. 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 MirrorMe3D Modeling System?

MirrorMe3D Modeling System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Mirrorme3D, LLC. The 510(k) number is K212981.

When did MirrorMe3D Modeling System receive FDA 510(k) clearance?

MirrorMe3D Modeling System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K212981.

Who is the listed applicant for MirrorMe3D Modeling System?

The FDA 510(k) record lists Mirrorme3D, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MirrorMe3D Modeling System?

The FDA product code for MirrorMe3D Modeling System is LLZ.

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, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

Official Source

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