K223909
- 510(k) number
- K223909
- Device name
- R2GATE Lite TM
- Applicant
- Megagen Implant Co., Ltd. KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-10-20
- Date received
- 2022-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K223909.pdf
Official FDA record: K223909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.