The following data is part of a premarket notification filed by Qr S.r.l. with the FDA for Newtom Vgi And Newtom 5g.
| Device ID | K130442 |
| 510k Number | K130442 |
| Device Name: | NEWTOM VGI AND NEWTOM 5G |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | QR S.R.L. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Berthoin Claude |
| Correspondent | Berthoin Claude QR S.R.L. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-07-03 |