K213263 is an FDA 510(k) clearance for the OnyxCeph. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Image Instruments GmbH (09123 Chemnitz, DE). The FDA issued a Cleared decision on January 4, 2023, 461 days after receiving the submission on September 30, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K213263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | January 04, 2023 |
| Days to Decision | 461 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |