The following data is part of a premarket notification filed by Media Lab S.r.l. with the FDA for Implant 3d.
| Device ID | K153091 |
| 510k Number | K153091 |
| Device Name: | IMPLANT 3D |
| Classification | System, Image Processing, Radiological |
| Applicant | Media Lab S.r.l. Via Trieste 4 Follo, IT 19020 |
| Contact | Massimo Ivani |
| Correspondent | Massimo Ivani Media Lab S.r.l. Via Trieste 4 Follo, IT 19020 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2016-02-25 |
| Summary: | summary |