K192766 is an FDA 510(k) clearance for the Digital Intraoral Imaging Plate System. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Fsusen Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 5, 2019, 66 days after receiving the submission on September 30, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K192766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2019 |
| Decision Date | December 05, 2019 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |