uAngio AVIVA CX
FDA 510(k) K243376 · Shanghai United Imaging Healthcare Co., Ltd.
510(k) numberK243376
Submission
- Device name
- uAngio AVIVA CX
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN - Received
- October 30, 2024
- Decision date
- April 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code OWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | DRTECH Corporation | 08/19/2026SE |
| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
| K260607 | Shield System (Siemens 30x40)OWB · Special | Radiaction , Ltd. | 07/31/2026SE |
| K253670 | SmartCT (R3.0 (L10))OWB · Abbreviated | Philips Medical Systems B.V. | 07/10/2026SE |
| K252735 | C-beamOWB · Traditional | Pulmera, Inc. | 05/22/2026SE |
| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/23/2026SE |
| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
More from Genoray Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | 08/21/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | 07/28/2026SE |
| K260113 | uMR AstraLNH · Traditional | 05/22/2026SE |
| K253077 | uOmnispace.MRQIH · Traditional | 04/22/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | 02/13/2026SE |
| K253173 | uCT 780 with uWS-CT-Dual Energy AnalysisJAK · Traditional | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | 11/26/2025SE |
| K252371 | uMR 680LNH · Special | 09/25/2025SE |
| K250045 | uWS-Angio ProLLZ · Traditional | 09/24/2025SE |
Questions and answers
When was uAngio AVIVA CX cleared by the FDA?
uAngio AVIVA CX (K243376) received a 510(k) decision of Substantially Equivalent on April 28, 2025, 180 days after the submission was received.
What is the product code of K243376?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.