uOmniscan
FDA 510(k) K243666 · Shanghai United Imaging Healthcare Co., Ltd.
510(k) numberK243666
Submission
- Device name
- uOmniscan
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN - Received
- November 27, 2024
- Decision date
- June 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
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| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 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 uOmniscan cleared by the FDA?
uOmniscan (K243666) received a 510(k) decision of Substantially Equivalent on June 17, 2025, 202 days after the submission was received.
What is the product code of K243666?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.