The following data is part of a premarket notification filed by 3diemme Ltd. with the FDA for 3diemme Realguide.
| Device ID | K173041 |
| 510k Number | K173041 |
| Device Name: | 3DIEMME RealGUIDE |
| Classification | System, Image Processing, Radiological |
| Applicant | 3DIEMME Ltd. Via Risorgimento 9 Cantu, IT 22063 |
| Contact | Alessandro Montroni |
| Correspondent | Lara Luzak Registar Corp 144 Research Drive Hampton, VA 23666 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08050038830058 | K173041 | 000 |
| 08050038830041 | K173041 | 000 |
| 08050038830034 | K173041 | 000 |
| 08050038830027 | K173041 | 000 |
| 08050038830010 | K173041 | 000 |
| 08050038830003 | K173041 | 000 |