PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
FDA 510(k) clearance K221144 · decided 2022-05-13
Clearance details
- K-number
- K221144
- Device name
- PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
- Applicant
- Radisen Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-20
- Decision date
- 2022-05-13
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.