VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
FDA 510(k) clearance K223917 · decided 2023-06-17
Clearance details
- K-number
- K223917
- Device name
- VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
- Applicant
- Vinno Technology (Suzhou) Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2022-12-29
- Decision date
- 2023-06-17
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.