The following data is part of a premarket notification filed by Qr S.r.l. with the FDA for Newtom Vgi Evo.
| Device ID | K151612 |
| 510k Number | K151612 |
| Device Name: | NewTom VGi Evo |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | QR S.r.l. Via Silvestrini 20 Verona, IT 37135 |
| Contact | Lorenzo Bortolotti |
| Correspondent | Simona Daidone Thema S.r.l. Via Saragat 5 Imola, IT 40026 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2016-03-31 |
| Summary: | summary |