The following data is part of a premarket notification filed by Qr S.r.l. with the FDA for Newtom 5g / Newtom 5g Version Fp.
| Device ID | K110260 |
| 510k Number | K110260 |
| Device Name: | NEWTOM 5G / NEWTOM 5G VERSION FP |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | QR S.R.L. VIA SILVESTRINI 20 Verona, Vr, IT 37135 |
| Contact | Lorenzo Bortolotti |
| Correspondent | Lorenzo Bortolotti QR S.R.L. VIA SILVESTRINI 20 Verona, Vr, IT 37135 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-28 |
| Decision Date | 2011-04-06 |
| Summary: | summary |