K210312 is an FDA 510(k) clearance for the PlutoX Digital Intraoral X-Ray Imaging System. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Iray Technology Taicang , Ltd. (Taicang, CN). The FDA issued a Cleared decision on April 23, 2021, 79 days after receiving the submission on February 3, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K210312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2021 |
| Decision Date | April 23, 2021 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH — System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |