K190096 is an FDA 510(k) clearance for the R2GATE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Megagen Implant Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on June 26, 2019, 155 days after receiving the submission on January 22, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K190096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2019 |
| Decision Date | June 26, 2019 |
| Days to Decision | 155 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 |