Medical Image Post-processing Software (uOmnispace.CT) (K242624)
Description
Medical Image Post-processing Software (uOmnispace.CT) by Shanghai United Imaging Healthcare Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242624
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. Medical Image Post-processing Software (uOmnispace.CT) (K242624) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare ... | 2024 |
| K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | 2020 |
Trace the full predicate network for K242624
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.