VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
FDA 510(k) clearance K223920 · decided 2023-06-17
Clearance details
- K-number
- K223920
- Device name
- VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
- 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.