# K212981: MirrorMe3D Modeling System

- Pathway: 510(k) (Traditional)
- Applicant: Mirrorme3D, LLC
- Decided: Apr 22, 2022 after 217 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924630 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 4.
- K161634: IPS CaseDesigner, Nobel Biocare AB (2016) Summary page 4.

## Indications for use
The MirrorMe3D Modeling System is intended for use as an image processing system for the transfer of 3D medical images. The MirrorMe3D Modeling System is also intended as a visualization system for measuring and treatment planning for aesthetic facial soft tissue. The input data is processed by the System using off-the-shelf modeling software and the result is an output data file that may then be provided as a digital model or used as input for the additive manufacturing of a physical anatomic model, which is not for diagnostic use. The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use. MirrorMe3D trained personnel will use off-the-shelf software to assist users in creating the 3D virtual (or digital) model that depicts the surgeon's intended outcome. The anatomic models are not for diagnostic use.

Source page: https://510kreport.com/device/K212981
Methodology: https://510kreport.com/methodology