The following data is part of a premarket notification filed by A.t.s. Applicazione Tecnologie Speciali S.r.l. with the FDA for Primo S.
| Device ID | K211542 |
| 510k Number | K211542 |
| Device Name: | PRIMO S |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | A.T.S. Applicazione Tecnologie Speciali S.R.L. Via Alessandro Volta, 10 Torre De Roveri, IT 24060 |
| Contact | Livia Pillitteri |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-07-09 |