Class Class II
uMI Panorama (K223325)
Description
uMI Panorama by Shanghai United Imaging Healthcare Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223325
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeKPS
Regulation Number892.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223325
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. uMI Panorama (K223325) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193241 | Emission Computed Tomography System | Shanghai United Imaging Healthcare ... | 2020 |
| K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare ... | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232712 | uMI Panorama | Shanghai United Imaging Healthcare ... | 2023 |
| K231572 | uMI Panorama | Shanghai United Imaging Healthcare ... | 2023 |
Trace the full predicate network for K223325
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.