1212FCA
FDA 510(k) clearance K202722 · decided 2020-10-26
Clearance details
- K-number
- K202722
- Device name
- 1212FCA
- Applicant
- Rayence Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-17
- Decision date
- 2020-10-26
- Days to decision
- 39 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hwaseong-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.