Class Class II
uMI Panvivo (K241596)
Description
uMI Panvivo by Shanghai United Imaging Healthcare Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241596
Clearance Date2024-08-15
Clearance TypeTraditional
Product CodeKPS
Regulation Number892.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241596
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 Panvivo (K241596) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-... | Shanghai United Imaging Healthcare ... | 2023 |
| 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 |
|---|---|---|---|
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare ... | 2024 |
Trace the full predicate network for K241596
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.