The following data is part of a premarket notification filed by Qr S.r.l. with the FDA for Newtom 5g.
| Device ID | K142222 |
| 510k Number | K142222 |
| Device Name: | NewTom 5G |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | QR S.r.l. Via Silverstrini 20 Verona, IT |
| Contact | Lorenzo Bortolotti |
| Correspondent | Testa Marisa THEMA Srl Via G. Saragat N.5 Imola, IT |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-13 |
| Decision Date | 2015-01-26 |