K223909 is an FDA 510(k) clearance for the R2GATE Lite TM. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Megagen Implant Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on October 20, 2023, 295 days after receiving the submission on December 29, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K223909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2022 |
| Decision Date | October 20, 2023 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |