K211542 is an FDA 510(k) clearance for the PRIMO S. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by A.T.S. Applicazione Tecnologie Speciali S.R.L. (Torre De Roveri, IT). The FDA issued a Cleared decision on July 9, 2021, 51 days after receiving the submission on May 19, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K211542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2021 |
| Decision Date | July 09, 2021 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |