uAngio AVIVA CX
by Shanghai United Imaging Healthcare Co., Ltd.
510(k) K253726
uAngio AVIVA CX is a Class II device made by Shanghai United Imaging Healthcare Co., Ltd., cleared under FDA 510(k) K253726 on 21 Aug 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253726 | Date21 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K253726
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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