Class Class II
uWS-Angio Basic (K243632)
Description
uWS-Angio Basic by Shanghai United Imaging Healthcare Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243632
Clearance Date2025-05-12
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243632
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. uWS-Angio Basic (K243632) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024 |
| K230955 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2023 |
| K183170 | uWS-CT | Shanghai United Imaging Healthcare ... | 2019 |
Trace the full predicate network for K243632
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.