Class Class II
uMR Omega (K243122)
Description
uMR Omega by Shanghai United Imaging Healthcare Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243122
Clearance Date2025-05-21
Clearance TypeTraditional
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243122
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. uMR Omega (K243122) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240540 | uMR Omega | Shanghai United Imaging Healthcare ... | 2024 |
| K230152 | uMR Omega | Shanghai United Imaging Healthcare ... | 2023 |
| K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare ... | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243547 | uMR Ultra | Shanghai United Imaging Healthcare ... | 2025 |
Trace the full predicate network for K243122
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.