FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
R2GATE Lite TM
K Number: K223909
·
Decision Oct 20, 2023
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
1
Review Days
295
Basic Information
- Device Name
- R2GATE Lite TM
- K Number
- K223909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MegaGen Implant Co. Ltd
- Date Received
- December 29, 2022
- Decision Date
- October 20, 2023
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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