Class Class II
LVivo Software Application (K240553)
Description
LVivo Software Application by Dia Imaging Analysis, Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240553
Clearance Date2024-10-04
Clearance TypeSpecial
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240553
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. LVivo Software Application (K240553) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222970 | LVivo IQS | Dia Imaging Analysis, Ltd. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243862 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2025 |
| K243235 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2025 |
Trace the full predicate network for K240553
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.