Bladder Scanner
FDA 510(k) clearance K230986 · decided 2023-12-29
Clearance details
- K-number
- K230986
- Device name
- Bladder Scanner
- Applicant
- Avantsonic Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-06
- Decision date
- 2023-12-29
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Chongqing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.