FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
K Number: K221144
·
Decision May 13, 2022
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
2
Review Days
23
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Basic Information
- Device Name
- PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
- K Number
- K221144
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radisen Co., Ltd.
- Date Received
- April 20, 2022
- Decision Date
- May 13, 2022
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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Other Clearances by Radisen Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213520 | AXIR-CX | Aug 19, 2022 | Substantially Equivalent |