The following data is part of a premarket notification filed by Mirrorme3d, Llc with the FDA for Mirrorme3d Modeling System.
| Device ID | K212981 |
| 510k Number | K212981 |
| Device Name: | MirrorMe3D Modeling System |
| Classification | System, Image Processing, Radiological |
| Applicant | MirrorMe3D, LLC 222 W 37th St., Suite 1501 New York, NY 10018 |
| Contact | Jordan Mills |
| Correspondent | Jordan Mills MirrorMe3D, LLC 222 W 37th St., Suite 1501 New York, NY 10018 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-17 |
| Decision Date | 2022-04-22 |