RAYSCAN a-Expert3D
FDA 510(k) clearance K190812 · decided 2019-04-24
Clearance details
- K-number
- K190812
- Device name
- RAYSCAN a-Expert3D
- Applicant
- Ray Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-29
- Decision date
- 2019-04-24
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- OAS
- Device class
- 2
- Regulation number
- 892.1750
- 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.